Anchors and methods for intestinal bypass sleeves

ABSTRACT

A gastrointestinal device for implanting within a pylorus, a duodenal bulb, and a duodenum of a patient&#39;s gastrointestinal tract includes an expandable structure includes a proximal portion having a plurality of spring arms and a distal portion having a plurality of spring arms, the proximal and distal portions coupled by a rigid central cylinder having a diameter capable of fitting within the pylorus and having a length greater than a width of the pylorus. A membrane is coupled to and covering at least a portion of one of the proximal portion and the distal portion of the expandable structure. An intestinal bypass sleeve is coupled to at least one of the proximal and distal portions of the expandable structure and having a length sufficient to extend at least partially into the duodenum. In the expanded configuration, the proximal portion has a diameter larger than a maximum opening diameter of the pylorus and further wherein, in the expanded configuration, the distal portion has a diameter larger than a maximum opening diameter of the pylorus.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Non-Provisional applicationSer. No. 13/360,689 filed Jan. 28, 2013 which claims benefit under 35U.S.C. section 119(e) of U.S. provisional patent application 61/462,156,filed Jan. 28, 2011, and U.S. provisional patent application 61/519,507,filed May 24, 2011, both of which are herein incorporated by referencein their entirety. U.S. Non-Provisional application Ser. No. 13/360,689filed Jan. 28, 2013 is a continuation-in-part of each of the followingapplications, each of which are herein incorporated by reference intheir entirety: (1) U.S. patent application Ser. No. 12/752,697, filedApr. 1, 2010, which claims the benefit of U.S. provisional patentapplication 61/211,853, filed Apr. 3, 2009; (2) U.S. patent applicationSer. No. 12/833,605, filed Jul. 9, 2010, which claims the benefit ofU.S. provisional patent application 61/270,588, filed Jul. 10, 2009; (3)U.S. patent application Ser. No. 12/986,268, filed Jan. 7, 2011, whichclaims the benefit of U.S. provisional patent application 61/335,472,filed Jan. 7, 2010; and (4) U.S. patent application Ser. No. 13/298,867,filed Nov. 17, 2011, which claims the benefit of U.S. provisional patentapplication 61/458,060, filed Nov. 17, 2010.

TECHNICAL FIELD

This invention generally relates to implants placed withingastrointestinal systems, including the esophagus, the stomach and theintestines. In particular it relates to implant systems havingcomponents implantable and removable using endoscopic techniques fortreatment of obesity, diabetes, reflux, gastroparesis and othergastrointestinal conditions.

BACKGROUND

Bariatric surgery procedures, such a sleeve gastrectomy, the Rouen-Ygastric bypass (RYGB) and the bileo-pancreatic diversion (BPD), modifyfood intake and/or absorption within the gastrointestinal system toeffect weight loss in obese patients. These procedures affect metabolicprocesses within the gastrointestinal system, by either short circuitingcertain natural pathways or creating different interaction between theconsumed food, the digestive tract, its secretions and theneuro-hormonal system regulating food intake and metabolism. In the lastfew years there has been a growing clinical consensus that obesepatients who undergo bariatric surgery see a remarkable resolution oftheir type-2 Diabetes Mellitus (T2DM) soon after the procedure. Theremarkable resolution of diabetes after RYGB and BPD typically occurstoo fast to be accounted for by weight loss alone, suggesting there maybe a direct impact on glucose homeostasis. The mechanism of thisresolution of T2DM is not well understood, and it is quite likely thatmultiple mechanisms are involved.

One of the drawbacks of bariatric surgical procedures is that theyrequire fairly invasive surgery with potentially serious complicationsand long patient recovery periods. In recent years, there is anincreasing amount of ongoing effort to develop minimally invasiveprocedures to mimic the effects of bariatric surgery using minimallyinvasive procedures. One such procedure involves the use ofgastrointestinal implants that modify transport and absorption of foodand organ secretions. For example, U.S. Pat. No. 7,476,256 describes animplant having a tubular sleeve with anchoring barbs, which offer thephysician limited flexibility and are not readily removable orreplaceable. Moreover, stents with active fixation means, such as barbsthat deeply penetrate into surrounding tissue, may potentially causetissue necrosis and erosion of the implants through the tissue, whichcan lead to complications, such as bacterial infection of the mucosaltissue or systemic infection. Also, due to the intermittent peristalticmotion within the digestive tract, implants such as stents have atendency to migrate.

Gastroparesis is a chronic, symptomatic disorder of the stomach that ischaracterized by delayed gastric emptying in the absence of mechanicalobstruction. The cause of gastroparesis is unknown, but it may be causedby a disruption of nerve signals to the intestine. The three most commonetiologies are diabetes mellitus, idiopathic, and postsurgical. Othercauses include medication, Parkinson's disease, collagen vasculardisorders, thyroid dysfunction, liver disease, chronic renalinsufficiency, and intestinal pseudo-obstruction. The prevalence ofdiabetic gastroparesis (DGP) appears to be higher in women than in men,for unknown reasons.

Diabetic gastroparesis affects about 40% of patients with type 1diabetes and up to 30% of patients with type 2 diabetes and especiallyimpacts those with long-standing disease. Both symptomatic andasymptomatic DGP seem to be associated with poor glycemic control bycausing a mismatch between the action of insulin (or an oralhypo-glycemic drug) and the absorption of nutrients. Treatment ofgastroparesis depends on the severity of the symptoms.

SUMMARY

According to various embodiments, the present invention provides for anapparatus and method to place and anchor an intestinal bypass sleevewithin the pyloric antrum, pylorus, duodenum and jejunum. Thegastrointestinal implant herein disclosed can be inserted endoscopically(when the device is loaded into a delivery catheter) through the mouth,throat, stomach and intestines. The gastrointestinal implant deviceincludes a flexible thin-walled sleeve and an expandable anchor attachedto the proximal end of the sleeve; secondary anchors may also anchorother portions of the thin-walled sleeve.

The present invention herein disclosed (with a short bypass sleeve or nobypass sleeve) can also be used to hold open the pylorus and may help toreduce the symptoms of gastroparesis, by allowing the stomach contentsto exit the stomach easier through the pylorus into the duodenum. Anactive pumping means may also be attached to the expandable anchor toactively pump the stomach contents from the pyloric antrum into theduodenum.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional view of a portion of the digestive tract ina human body with an intestinal bypass sleeve implanted in the duodenumfrom the pylorus to the ligament of treitz. The sleeve is held in placeat the pylorus by an expandable anchor that anchors on the pylorus.

FIG. 2 is a cross-sectional view of a portion of the digestive tract ina human body with an endoscope inserted through the mouth, esophagus andstomach to the pylorus.

FIG. 3A is a drawing of an over-the-wire sizing balloon that may be usedto dilate and measure (size) the intestinal tract and pylorus anatomy.

FIG. 3B is a drawing of a rapid exchange or monorail sizing balloon thatmay be used to dilate and measure (size) the intestinal tract andpylorus anatomy.

FIG. 4 is a cross-sectional view of a portion of the digestive tract ina human body. An endoscope is inserted through the mouth, esophagus andstomach to the pylorus. An over-the-wire sizing balloon is insertedthrough the working channel of the endoscope over a guidewire and isadvanced across the pyloric opening. The balloon is inflated with salineor contrast media to a low pressure to open the pylorus and duodenum andallow measurement of the lumen diameter of the pyloric antrum, pylorusand duodenal bulb.

FIG. 5 is a cross-sectional drawing of the pyloric antrum, pylorus,duodenal bulb and duodenum. An expandable anchor and intestinal bypasssleeve is implanted into the pylorus.

FIG. 6 is a drawing of an expandable anchor according to exemplaryembodiments of the invention.

FIG. 7 is a drawing of a flat representation of the circumference of theexpandable anchor disclosed in FIG. 2. The anchor can be laser cut fromround tubing or a flat sheet of Nitinol.

FIG. 8 is a drawing of a flat representation of the circumference of theexpandable anchor disclosed in FIG. 2. The expandable anchor can belaser cut from round tubing or flat sheet of Nitinol. The individualspring arm elements of the anchor are cut at a bias angle to thelongitudinal axis.

FIG. 9 is a drawing of exemplary heat set mandrels for forming the shapeof the anchor from the laser cut shape of FIG. 7 and FIG. 8 to the finalshape of the anchor in FIG. 4.

FIG. 10 is a sectional view of a delivery catheter for the expandableanchor and intestinal bypass sleeve implanted.

FIG. 11 is a sectional view of an anchor and sleeve implanted into apylorus and duodenal bulb and duodenum. The expandable anchor is coveredwith a membrane on both the inside and outside surfaces of the anchor toclose the openings in between the spring arm elements. An intestinalbypass sleeve is attached to the expandable anchor.

FIG. 12 is a sectional view of a recovery catheter for removing theexpandable anchor and intestinal bypass sleeve from the humangastrointestinal tract.

FIG. 13 is a sectional view of the expandable anchor in the collapsedstate with the outer sheath of the recovery catheter covering andconstraining the expandable anchor.

FIG. 14 is a sectional view of an alternative embodiment of an anchorand sleeve implanted into the pylorus and duodenal bulb and duodenum.

FIG. 15 is a sectional view of an alternative embodiment of an anchorand sleeve implanted into the pylorus and duodenal bulb and duodenum.

FIG. 16 is a sectional view of an alternative embodiment of theinvention herein disclosed implanted into the pylorus and duodenal bulband duodenum. The through lumen of the expandable anchor contains a duckbill type anti-reflux valve and a flow limiter.

FIG. 17 is a sectional view of an alternative embodiment of theinvention herein disclosed implanted into the pylorus and duodenal bulband duodenum. The through lumen of the expandable anchor contains a balland cage anti-reflux valve and alternatively a bi-leaflet anti-refluxvalve.

FIG. 18 shows an alternative embodiment of an expandable anchor.

FIG. 19 is a partial cross-sectional drawing of the pyloric antrum,pylorus, duodenal bulb and duodenum. An alternative embodiment of anexpandable anchor intestinal bypass sleeve is implanted into the pyloricantrum, pylorus, duodenal bulb and duodenum.

FIG. 20 shows an alternative embodiment of an expandable anchor.

FIG. 21A is a drawing of a flat representation of the expandable anchorshown in FIG. 20.

FIG. 21B is a drawing of a cylindrical mandrel for heat setting theexpandable anchor to the hourglass shape as in FIG. 20.

FIG. 22 shows an alternative embodiment of an expandable anchor.

FIG. 23 shows an alternative embodiment of an expandable anchor.

FIG. 24 is a drawing of expandable anchor of FIG. 23 in a compressedstate, with a sheath constraining it on the outside diameter.

FIG. 25 shows an alternative embodiment of an expandable anchor formedfrom wire.

FIG. 26 shows an alternative embodiment of an expandable anchor formedfrom wire.

FIG. 27 shows an alternative embodiment of an expandable anchor formedfrom wire.

FIG. 28 shows an alternative embodiment of an expandable anchor formedfrom wire.

FIG. 29 shows an alternative embodiment of an expandable anchor.

FIG. 30 shows an alternative embodiment of an expandable anchor.

FIG. 31 is a cross-sectional view of the pyloric antrum, pylorus,duodenal bulb and the duodenum in the human body. An expandable anchorand intestinal bypass sleeve is implanted across the pylorus.

FIG. 32 shows an alternative embodiment of an expandable anchor formedin the shape of a toroidal-shaped coil.

FIG. 33A is a drawing of an alternative embodiment of an expandableanchor formed in the shape of a toroidal-shaped coil. The coil may havesmall tissue penetrating anchors on the outer surface of the coil.

FIG. 33B is a drawing of an alternative embodiment of an expandableanchor formed in the shape of a toroidal-shaped coil. The direction ofthe winding of the coil is reversed to cancel out the helical twistingaction of the spring.

FIG. 33C is a drawing of an alternative embodiment of an expandableanchor formed in the shape of a toroidal-shaped coil as previouslydisclosed. The spring is wound to have double helices that are 180degrees offset from each other.

FIG. 34A is an alternative embodiment of a toroidal spring that is madefrom laser cutting a pattern into a round piece of Nitinol tubing. TheNitinol tubing is laser cut in the straight tubular shape and then thecut tube is then formed into the toroidal shape.

FIG. 34B is an alternative embodiment of a toroidal spring that is madefrom laser cutting a pattern into a round piece of Nitinol tubing. TheNitinol tubing is laser cut in the straight round tubular shape and thenit is formed into the toroidal shape. Alternatively, the part may be cutfrom a flat sheet of Nitinol and then shape set into the final shape.

FIG. 35 is a drawing of an alternative embodiment of an expandableanchor. The drawing shows additional embodiments for the expandableanchors in FIG. 32, FIG. 33 and FIG. 34.

FIG. 36 is an assembly drawing with the expandable anchors in FIG. 32,FIG. 33, FIG. 34 and

FIG. 37 is a drawing showing an assembly drawing of a fixed diametercylinder for the central pyloric portion of the invention hereindisclosed.

FIG. 38 is drawing showing of a central pyloric portion of the inventionherein disclosed in which the mid portion allows for opening and closingof the pylorus, while there is a first and a second ring which are fixedrigidly together. The expandable anchors in the pyloric antrum and theduodenal bulb are tethered to the first and second rings.

FIG. 39 is a sectional view of the invention herein disclosed implantedinto the pyloric antrum, pylorus and duodenal bulb and duodenum. Theanchoring device is comprised of two disk-shaped expandable anchors thatare connected to a central cylinder which has a thin-walled compliantmembrane over the central portion to allow opening and closing of thepyloric aperture.

FIG. 40 is a sectional view of the invention herein disclosed implantedinto the pyloric antrum, pylorus and duodenal bulb and duodenum. Theanchoring device is comprised of two disk-shaped expandable anchors thatare connected to a central cylinder. The lumen of the anchoring devicehas a one-way anti-reflux valve and a flow limiter.

FIG. 41 is a sectional view of the invention herein disclosed implantedinto the pyloric antrum, pylorus and duodenal bulb and duodenum. Theanchoring device is comprised of two disk-shaped expandable anchors thatare connected to a central cylinder. The diameter of the centralcylinder is elastic and the diameter can be compressed to allow areduced diameter of the anchor to allow the anchor to be loaded onto asmaller diameter catheter than with a fixed diameter central cylinder.

FIG. 42 is a sectional view of the invention herein disclosed implantedinto the pyloric antrum, pylorus and duodenal bulb and duodenum. Theanchoring device is comprised of two disk-shaped expandable anchors thatare connected by a thin-walled tubular membrane. The thin-walled tubularmembrane allows normal pylorus opening and closing.

FIG. 43 is a sectional view of the invention herein disclosed implantedinto the duodenal bulb and duodenum. The anchoring device is comprisedof two disk-shaped expandable anchors that are connected to a centralcylinder. The lumen of the anchoring device has an optional one-wayanti-reflux valve and an optional flow limiter. The anti-reflux valveand flow-limiter can be used together in combination or separately onthe device.

FIG. 44 is a sectional view of the invention herein disclosed. Theanchoring device is comprised of two disk-shaped expandable anchors thatare connected to a central cylinder. The anchoring device is implantedinto the pyloric antrum and the intestinal bypass sleeve is implantedfrom the pyloric antrum to the duodenum.

FIG. 45A is a sectional view of the invention herein disclosed. Theanchoring device is comprised of two disk-shaped expandable anchors thatare connected to a central cylinder. Four additional expandable anchorsare attached to the thin-walled sleeve and are implanted into thepyloric antrum.

FIG. 45B is a drawing of a flat braided wire form that may be used as anexpandable anchor.

FIG. 46 is a drawing of an alternative embodiment of the inventionherein disclosed. The expandable anchor is comprised of a hollow tubularbraided structure of wire. The wire form has been shaped to conform tothe shape of the pylorus and the duodenal bulb.

FIG. 47 is a drawing of an alternative embodiment of the inventionherein disclosed. The expandable anchor is comprised of hollow tubularbraided structure of wire. The wire form has been shaped to conform tothe shape of the pylorus and the duodenal bulb. The expandable anchorand the intestinal bypass sleeve have been implanted into a humanpylorus and duodenal bulb.

FIG. 48 is a drawing of an alternative embodiment of the inventionherein disclosed. The expandable anchor is comprised of a hollow tubularbraided structure of wire. The wire form has been shaped to conform tothe shape of the pylorus and the duodenal bulb. The expandable anchorhas an annular groove formed in wall the duodenal bulb portion of theexpandable anchor. The annular groove is sized to provide for a modularconnection means between an expandable anchor and intestinal bypasssleeve.

FIG. 49 is a drawing of an alternative embodiment of the inventionherein disclosed implanted into a pyloric antrum, pylorus, duodenalbulb, and duodenum. The expandable anchor is comprised of a hollowtubular braided structure of wire. The wire form has been shaped toconform to the shape of the pylorus and the duodenal bulb. Theexpandable anchor has an annular grove formed in wall the duodenal bulbportion of the expandable anchor. The annular groove is sized to providefor a modular connection means between an expandable anchor andintestinal bypass sleeve. An intestinal bypass sleeve with an expandableanchor attached to the end of the sleeve is attached to the annulargroove in the anchor in the pylorus.

FIG. 50 is a drawing showing the process steps for the manufacturing ofthe expandable anchor as in FIG. 46, FIG. 47 and FIG. 48.

FIG. 51 is drawing of an alternative embodiment of the expandable anchorherein disclosed.

FIG. 52A is a drawing of a pyloric antrum, pylorus, duodenal bulb andduodenum and of the expandable anchor of FIG. 52.

FIG. 52B is a drawing of a pylorus and of the expandable anchor of FIG.52 implanted into it.

FIG. 53 is drawing of an alternative embodiment of the expandable anchorherein disclosed.

FIG. 54 is a drawing of an alternative embodiment of an expandableanchor that has optional barbs to provide for an additional securingmeans to the pylorus.

FIG. 55 is a sectional view of the invention herein disclosed implantedinto the pyloric antrum, pylorus and duodenal bulb and duodenum. Theanchoring device is comprised of two disk-shaped expandable anchors thatare connected to a central cylinder. The diameter of the centralcylinder is fixed, but it may also be designed to allow it to be reducedin diameter during loading of the device onto a catheter. The length ofthe central cylinder is adjusted to allow the spacing between the twodisks to be variable in spacing.

FIG. 56 is a sectional view of the invention herein disclosed implantedinto the pyloric antrum, pylorus and duodenal bulb and duodenum. Theanchoring device is comprised of two toroidal-shaped expandable anchorsthat are connected to a central cylinder. The diameter of the centralcylinder is fixed, but it may also be elastic to allow it to be reducedin diameter during loading of the device onto a catheter. An optionalneedle, suture, T-bar, hollow helical anchor or screw type anchor isinserted into and or through the tissue of the pylorus, pyloric antrumor duodenum to provide additional anchoring and securement of theintestinal bypass sleeve anchoring device to the pylorus anatomy.Additional anchoring means may include a T-Bar and suture.

FIG. 57 is a sectional view of the invention herein disclosed implantedinto a pylorus, duodenal bulb and duodenum. An expandable ring is sizedlarge enough in diameter to engage the wall of the stomach pyloricantrum. The central portion of the device is constructed of a ridgedfixed diameter cylinder, or alternatively a compressible cylinder or athin-walled sleeve. An optional needle, suture, T-bar, hollow helicalanchor or screw-type anchor is inserted into and or through the tissueof the pylorus, pyloric antrum or duodenum to provide additionalanchoring and securement of the intestinal bypass sleeve anchoringdevice to pylorus anatomy or other suitable location.

FIG. 58 is a cross-sectional view of a portion of the digestive tract ina human body. An intestinal bypass sleeve is implanted in the duodenumfrom the pylorus to the ligament of treitz. The sleeve is held in placeat the pylorus by an expandable anchor that anchors on the pylorusoptional secondary expandable anchors anchor the sleeve at additionallocations in the duodenum and jejunum. An expandable anchor with ananti-reflux valve is implanted at the gastroesophageal (GE) junction tohelp resolve gastroesophageal reflux disease (GERD).

FIG. 59A is a drawing of an alternative embodiment of an expandableanchor.

FIG. 59B is a drawing of an alternative embodiment of an expandableanchor.

FIG. 59C is a drawing of an alternative embodiment of an expandableanchor.

FIG. 60 is a drawing of FIG. 59A implanted into a pylorus. AlternativelyFIG. 59A, FIG. 59B and FIG. 59C could also be implanted into the pyloricantrum, duodenal bulb or duodenum or GE junction.

FIG. 61A is a drawing of an intestinal bypass sleeve.

FIG. 61B is a drawing of an alternative embodiment of an intestinalbypass sleeve.

FIG. 62A is a drawing of an alternative embodiment of an intestinalbypass sleeve.

FIG. 62B is a drawing of an alternative embodiment of an intestinalbypass sleeve.

FIG. 63A is a drawing of an alternative embodiment of an intestinalbypass sleeve.

FIG. 63B is a drawing of an alternative embodiment of an intestinalbypass sleeve.

FIG. 64A is drawing of a hemispherical-shaped covering for an expandableanchor that is assembled from a sheet of polymer material into aspherical shape.

FIG. 64B is a drawing of hemispherical-shaped covering for an expandableanchor that is made by radial stretching a tube perform into a sphericalshape by blow-molding or mechanical stretching.

FIG. 64C is drawing of a hemispherical-shaped covering for an expandableanchor that is assembled from a sheet of polymer material into a tubularshape.

FIG. 65A is drawing of a hemispherical- or disk-shaped covering for anexpandable anchor that is assembled from sheet material into a sphericalor disk shape.

FIG. 65B is drawing of a disk-shaped covering for an expandable anchorthat is assembled from sheet material into a disk shape.

FIG. 65C is drawing of a hemispherical- or disk-shaped covering for anexpandable anchor that is assembled from tube and sheet material into adisk shape.

FIG. 66 is a drawing of an expandable anchor that has an Archimedesscrew-type pump and motor integrated into the central cylinder or thrulumen of the device. The Archimedes screw is used to control the flowrate of chyme and/or to pump chyme from the stomach into the duodenum.

FIG. 67 is a sectional drawing of a part of the anatomy, a pyloricantrum, pylorus, duodenal bulb, and duodenum. The expandable anchor ofFIG. 66 is implanted into the pyloric antrum, pylorus, duodenal bulb andduodenum.

FIG. 68 is a cross-sectional drawing of a portion of the digestive tractin a human body. The expandable anchor of FIG. 66 is implanted into thepyloric antrum, pylorus, duodenal bulb and duodenum. A secondaryArchimedes screw-type pump is attached to the first pump by means of aflexible drive shaft and is housed in a hollow flexible cannula that isattached to the expandable anchor.

FIG. 69A is a drawing an alternative embodiment of an expandable anchor.

FIG. 69B is a drawing of an alternative embodiment of an expandableanchor.

FIG. 70A is drawing of a piece of ePTFE tubing with an inner tube ofsilicone or latex inserted through the inside diameter of the ePTFE. TheePTFE tube in the final form can be use for covering an expandableanchor used to anchor an intestinal bypass sleeve. The covering for theexpandable anchor and the intestinal bypass sleeve can be formed intoone single unitary piece in some embodiments.

FIG. 70B is a longitudinal cross-section drawing of the ePTFE tube andsilicone tube shown in FIG. 70A.

FIG. 70C is a drawing of a mold cavity the ePTFE tube from FIG. 70A andFIG. 70B will be radially stretched and inflated into the shape of themold cavity. The radial expansion of the tube of ePTFE is like what waspreviously disclosed in FIG. 64B.

FIG. 71A is a drawing of a two mold cavities of FIG. 70C that are usedtogether to provide an enclosed cavity to limit the expansion of theePTFE during the blow-molding radial stretching process.

FIG. 71B is a drawing of the two mold cavities assembled one cavity halfon top of the other. The ePTFE tube and latex tubing are insertedthrough the central bore between the two mold halves.

FIG. 72A is a drawing of the two mold halves opened after the ePTFE tubehas been blow-molded to the shape of the mold cavities.

FIG. 72B is a drawing of the ePTFE tube removed from the mold cavityafter the blow-molding/radial stretching process is complete.

FIG. 72C is a drawing of the cross-section of the ePTFE tube andsilicone tube inflated, while the two tubes are still in the mold ofFIG. 71B, after the pressure is released.

FIG. 73 is a drawing of an alternate embodiment for a shape for the moldcavity for blow-molding the ePTFE tube.

FIG. 74 is a drawing of an alternate embodiment of a shape for the moldcavity for blow-molding the ePTFE tube.

FIG. 75 is a drawing of an alternate embodiment of a shape for the moldcavity for blow-molding the ePTFE tube.

FIG. 76 is a drawing of an alternate embodiment of a shape for the moldcavity for blow-molding the ePTFE tube.

FIG. 77A is a drawing of the final formed shape of the ePTFE tube afterblow-molding/radial stretching of the original cylindrical tube ofePTFE.

FIG. 77B is a drawing of an alternative embodiment the final formedshape of the ePTFE tube after blow-molding/radial stretching of theoriginal cylindrical tube of ePTFE.

FIG. 77C is a drawing of an alternative embodiment the final formedshape of the ePTFE tube after blow-molding/radial stretching of theoriginal cylindrical tube of ePTFE.

FIG. 77D is a drawing of an alternative embodiment the final formedshape of the ePTFE tube after blow-molding/radial stretching of theoriginal cylindrical tube of ePTFE.

FIG. 77E is a drawing of an alternative embodiment the final formedshape of the ePTFE tube after blow-molding/radial stretching of theoriginal cylindrical tube of ePTFE.

FIG. 78A is a drawing of the final formed shape of the ePTFE tube afterblow-molding/radial stretching of the original cylindrical tube ofePTFE. The anchor covering portion of the sleeve and the intestinalbypass sleeve are formed integrally into one sleeve.

FIG. 78B is a drawing of the final formed shape of the ePTFE tube afterblow-molding/radial stretching of the original cylindrical tube ofePTFE. The anchor covering portion of the sleeve and the intestinalbypass sleeve are formed integrally into one sleeve. The small-diameterend of the tube is started to be inverted inside to pull it inside toform an interior tube layer for the expandable anchor.

FIG. 78C is a drawing of the final formed shape of the ePTFE tube afterblow-molding/radial stretching of the original cylindrical tube ofePTFE. The anchor covering portion of the sleeve and the intestinalbypass sleeve are formed integrally into one sleeve. The small-diameterend of the tube is fully inverted inside forming an interior layer forthe expandable anchor.

FIG. 79A is a drawing of an alternative embodiment of the final formedshape of the ePTFE tube after blow-molding/radial stretching of theoriginal cylindrical tube of ePTFE. The anchor covering portion of thesleeve and the intestinal bypass sleeve are formed integrally into onesleeve.

FIG. 79B is a drawing of an alternative embodiment of the final formedshape of the ePTFE tube after blow-molding/radial stretching of theoriginal cylindrical tube of ePTFE. The anchor covering portion of thesleeve and the intestinal bypass sleeve are formed integrally into onesleeve. The small diameter end of the tube is started to be invertedinside to pull it inside to form an interior tube layer for theexpandable anchor.

FIG. 79C is a drawing of an alternative embodiment of the final formedshape of the ePTFE tube after blow-molding/radial stretching of theoriginal cylindrical tube of ePTFE. The anchor covering portion of thesleeve and the intestinal bypass sleeve are formed integrally into onesleeve. The small diameter end of the tube is fully inverted insideforming an interior layer for the expandable anchor.

FIG. 80A is a drawing of an alternative embodiment of the final formedshape of the ePTFE tube after blow-molding/radial stretching of theoriginal cylindrical tube of ePTFE. The anchor covering portion of thesleeve and the intestinal bypass sleeve are formed integrally into onesleeve.

FIG. 80B is a drawing of an alternative embodiment of the final formedshape of the ePTFE tube after blow-molding/radial stretching of theoriginal cylindrical tube of ePTFE. The anchor covering portion of thesleeve and the intestinal bypass sleeve are formed integrally into onesleeve. The small-diameter end of the tube is started to be invertedinside to pull it inside to form an interior tube layer for theexpandable anchor.

FIG. 81A is a drawing of an alternative embodiment of the final formedshape of the ePTFE tube after blow-molding/radial stretching of theoriginal cylindrical tube of ePTFE. The anchor covering portion of thesleeve and the intestinal bypass sleeve are formed integrally into onesleeve.

FIG. 81B is a drawing of an alternative embodiment of the final formedshape of the ePTFE tube after blow-molding/radial stretching of theoriginal cylindrical tube of ePTFE. The anchor covering portion of thesleeve and the intestinal bypass sleeve are formed integrally into onesleeve. The one end of the tube is started to be inverted inside to pullit inside to form an interior tube layer for the expandable anchor.

FIG. 81C is a drawing of an alternative embodiment of the final formedshape of the ePTFE tube after blow-molding/radial stretching of theoriginal cylindrical tube of ePTFE. The anchor covering portion of thesleeve and the intestinal bypass sleeve are formed integrally into onesleeve. The one end of the tube is fully inverted inside forming aninterior layer for the expandable anchor.

FIG. 82A is a drawing of an alternative embodiment of the final formedshape of the ePTFE tube after blow-molding/radial stretching of theoriginal cylindrical tube of ePTFE. The anchor covering portion of thesleeve and the intestinal bypass sleeve are formed integrally into onesleeve. The small diameter end of the tube is inverted inside to pull itinside to form an interior tube layer for the expandable anchor. Theinterior tube is formed into the shape of anti-reflux valve.

FIG. 82B is a drawing of an alternative embodiment of the final formedshape of the ePTFE tube after blow-molding/radial stretching of theoriginal cylindrical tube of ePTFE. The anchor covering portion of thesleeve and the intestinal bypass sleeve are formed integrally into onesleeve. The small diameter end of the tube is inverted inside to pull itinside to form an interior tube layer for the expandable anchor. Theinterior tube is formed into the shape of a restrictive stoma.

FIG. 82C is a drawing of an alternative embodiment of the final formedshape of the ePTFE tube after blow-molding/radial stretching of theoriginal cylindrical tube of ePTFE. The anchor covering portion of thesleeve and the intestinal bypass sleeve are formed integrally into onesleeve. The small-diameter end of the tube is inverted inside to pull itinside to form an interior tube layer for the expandable anchor. Theinterior tube is formed into the shape of a restrictive stoma and thenan anti-reflux valve in series.

FIG. 83A is a drawing of an alternative embodiment of the final formedshape of the ePTFE tube after blow-molding/radial stretching of theoriginal cylindrical tube of ePTFE. The anchor covering portion of thesleeve and the intestinal bypass sleeve are formed integrally into onesleeve. The small-diameter end of the tube is inverted inside to pull itinside to form an interior tube layer for the expandable anchor. Theinterior tube is formed into the shape of a restrictive stoma and thenan anti-reflux valve in series.

FIG. 83B is a drawing of an alternative embodiment of the final formedshape of the ePTFE tube after blow-molding/radial stretching of theoriginal cylindrical tube of ePTFE. The anchor covering portion of thesleeve and the intestinal bypass sleeve are formed integrally into onesleeve. The small-diameter end of the tube is inverted inside to pull itinside to form an interior tube layer for the expandable anchor. Theintestinal bypass sleeve has annular rings or corrugations molded intoit to allow for the sleeve to bend easier without kinking and to providefor more longitudinal elasticity.

FIG. 84 is a drawing of an alternative embodiment of the embodimentshown in FIG. 46. The expandable anchor is comprised of a hollow tubularbraided structure of wire. The wire form has been shaped to conform tothe shape of the pylorus and the duodenal bulb. Optional barbs and/orhooks provide for additional tissue penetration and anchoring.

FIG. 85 is a drawing of an expandable anchor. The expandable anchorincorporates optional barbs and/or hooks have been incorporated into theanchor to provide for tissue penetration and additional anchoring.

FIG. 86 is a drawing of an expandable anchor. The expandable anchorincorporates optional barbs and/or hooks have been incorporated into theanchor to provide for tissue penetration and additional anchoring.

FIG. 87 is a drawing of an expandable anchor. The expandable anchorincorporates optional barbs and/or hooks have been incorporated into theanchor to provide for tissue penetration and additional anchoring.

FIG. 88 is a drawing of an expandable anchor. The expandable anchorincorporates optional barbs and/or hooks have been incorporated into theanchor to provide for tissue penetration and additional anchoring.

FIG. 89 is a drawing of an expandable anchor in which the anchors antraldisk is larger in diameter than the duodenal bulb disk.

FIG. 90 is a drawing of an expandable anchor.

FIGS. 91-94 show various embodiments of anti-reflux valves for use inconjunction with an expandable anchor.

FIGS. 95-96 show various embodiments of anti-reflux valve frames havingflexing posts for use in conjunction with an expandable anchor.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1 is a sectional view of an embodiment of the invention implantedin a portion of a human digestive tract. As a person ingests food, thefood enters the mouth 100, is chewed, and then proceeds down theesophagus 101 to the lower esophageal sphincter at the gastro-esophagealjunction 102 and into the stomach 103. The food mixes with enzymes inthe mouth 100 and in the stomach 103. The stomach 103 converts the foodto a semi-fluid substance called chyme. The chyme enters the pyloricantrum 104 and exits the stomach 103 through the pylorus 106 and pyloricorifice 105. The pylorus (or pyloric sphincter) is a band of muscle thatfunctions to adjust the diameter of the pyloric orifice, which in turneffects the rate at which chyme exits the stomach. The pylorus (orphyloric sphincter) also has a width (or thickness), which is thedistance that the pylorus extends between the stomach and the duodenum.The small intestine is about 21 feet long in adults. The small intestineis comprised of three sections: the duodenum 112, jejunum 113 and ileum(not shown). The duodenum 112 is the first portion of the smallintestine and is typically 10-12 inches long. The duodenum 112 iscomprised of four sections: the superior, descending, horizontal andascending. The duodenum 112 ends at the ligament of treitz 109. Thepapilla of vater 108 is the duct that delivers bile and pancreaticenzymes to the duodenum 112. The duodenal bulb 107 is the portion of theduodenum which is closest to the stomach 103. As shown, an intestinalbypass sleeve 111 is implanted in the duodenum from the pyloric antrum104 and pylorus 106 to the ligament of treitz 109. The intestinal bypasssleeve 111 is held in place at the pylorus 106 by an expandable anchor110 that anchors on the pylorus 106.

In various exemplary embodiments, the sleeve 111 is integrally formedwith or coupled to the expandable anchor 110. According to otherexemplary embodiments, the sleeve 111 is removably or releasably coupledto the expandable anchor 110. According to various embodiments, thebypass sleeve has a diameter of between about 10 mm and about 35 mm.According to various embodiments, the bypass sleeve has a thickness ofbetween about 0.001 and about 0.015 inches. Exemplary structures forremovably or releasably coupling or attaching the sleeve 111 to theexpandable anchor 110 are disclosed for example in U.S. patentapplication Ser. No. 12/752,697, filed Apr. 1, 2010, entitled “ModularGastrointestinal Prostheses,” which is incorporated herein by reference.According to various embodiments, the sleeve 111 or the expandableanchor 110 (or both) are further coupled at the pylorus 106 using one ormore of the techniques described in either of U.S. patent applicationSer. No. 12/752,697 or U.S. patent application Ser. No. 12/833,605,filed Jul. 9, 2010, entitled “External Anchoring Configuration forModular Gastrointestinal Prostheses,” both of which are incorporatedherein by reference. According to various embodiments of the invention,the sleeve 111 may be configured and coupled to the expandable anchor110, using one or more of the configurations disclosed in U.S. patentapplication Ser. No. 12/986,268, filed Jan. 7, 2011, entitled“Gastrointestinal Prostheses Having Partial Bypass Configurations,”which is incorporated herein by reference.

FIG. 2 is a sectional view of a portion of the digestive tract in ahuman body. As shown, an endoscope 114 has been inserted through: themouth 100, esophagus 101, stomach 103 and pyloric antrum 104 to allowvisualization of the pylorus 106. Endoscopes 114 are used for diagnosticand therapeutic procedures in the gastrointestinal tract. The typicalendoscope 114 is steerable by turning two rotary dials 115 to causedeflection of the working end 116 of the endoscope. The working end ofthe endoscope or distal end 116, typically contains two fiber bundlesfor lighting 117, a fiber bundle for imaging 118 (viewing) and a workingchannel 119. The working channel 119 can also be accessed on theproximal end of the endoscope. The light fiber bundles and the imagefiber bundles are plugged into a console at the plug in connector 120.The typical endoscope has a working channel in the 2.6 to 3.2 mmdiameter range. The outside diameter is typically in the 8 to 12 mmdiameter range depending on whether the endoscope is for diagnostic ortherapeutic purposes.

FIG. 3A is a drawing of an over-the-wire sizing balloon 121 that is usedto measure the diameter of the pylorus 106, duodenal bulb 107, esophagus102, pyloric antrum 104 or other lumen in the GI tract. The sizingballoon is composed of the following elements: proximal hub 122,catheter shaft 124, distal balloon component 125, radiopaque markerbands 126, distal tip 127, guidewire lumen 128, inflation lumen 129.Distal balloon component 125 can be made from silicone, siliconepolyurethane copolymers, latex, nylon 12, PET (Polyethyleneterephthalate) Pebax (polyether block amide), polyurethane,polyethylene, polyester elastomer or other suitable polymer. The distalballoon component 125 can be molded into a cylindrical shape, into adogbone or a conical shape. The distal balloon component 125 can be madecompliant or non-compliant. The distal balloon component 125 can bebonded to the catheter shaft 124 with glue, heat bonding, solventbonding, laser welding or suitable means. The catheter shaft can be madefrom silicone, silicone polyurethane copolymers, latex, nylon 12, PET(Polyethylene terephthalate) Pebax (polyether block amide),polyurethane, polyethylene, polyester elastomer or other suitablepolymer. Section A-A in FIG. 3A is a cross-section of the catheter shaft124. The catheter shaft 124 if shown as a dual lumen extrusion with aguidewire lumen 128 and an inflation lumen 129. The catheter shaft 124can also be formed from two coaxial single lumen round tubes in place ofthe dual lumen tubing. The balloon is inflated by attaching a syringe(not shown) to a luer fitting side port 130. The sizing balloonaccommodates a guidewire through the guidewire lumen from the distal tip127 through the proximal hub 122. The sizing balloon can be filled withsaline or a radiopaque dye to allow visualization and measurement of thesize of the anatomy with a fluoroscope. The sizing balloon 121 has twoor more radiopaque marker bands 126 located on the catheter shaft toallow visualization of the catheter shaft and balloon position. Themarker bands 126 also serve as fixed known distance reference pointsthat can be measured to provide a means to calibrate and determine theballoon diameter with the use of the fluoroscope. The marker bands canbe made from tantalum, gold, platinum, platinum iridium alloys or othersuitable material.

FIG. 3B shows a rapid exchange sizing balloon 134 that is used tomeasure the diameter of the pylorus 106, duodenal bulb 107, esophagus101, pyloric antrum 104 or other lumen in the GI tract. The sizingballoon is composed of the following elements: proximal luer 131,catheter shaft 124, distal balloon component 125, radiopaque markerbands 126, distal tip 127, guidewire lumen 128, inflation lumen 129. Thematerials of construction will be similar to that of FIG. 4A. Theguidewire lumen 128 does not travel the full length of the catheter. Itstarts at the distal tip 127 and exits out the side of the catheter atdistance shorter than the overall catheter length. The guidewire 132 isinserted into the balloon catheter to illustrate the guidewire paththrough the sizing balloon. The sizing balloon catheter shaft changessection along its length from a single lumen at section B-B 133 to adual lumen at section A-A at 124. An alternative hourglass-shapedballoon 590 can be used for sizing the pylorus anatomy without dilatingthe pylorus aperture.

FIG. 4 is a sectional view of a portion of the digestive tract in ahuman body. As shown, an endoscope 114 is inserted through the mouth100, esophagus 101 and stomach 103 up to the pylorus 106. An over thewire sizing balloon 121 is inserted through the working channel 119 ofthe endoscope 114 over a guidewire and is advanced across the pyloricopening 105. The balloon is inflated with saline or contrast media to alow pressure to open the pylorus 106, pyloric antrum 104 and duodenalbulb 107 and to allow measurements to be taken.

FIG. 5 is a sectional view of the pyloric antrum 104, pylorus 106,duodenal bulb 107 and duodenum 112. An expandable anchor 110 andintestinal bypass sleeve 111 is implanted into the pylorus 106. Theexpandable anchor 110 is shown here without a covering material to allowfor better visualization of the expandable anchor 110. In variousexemplary embodiments, the expandable anchor 110 is not covered, whilein other exemplary embodiments, it is covered with a polymer membranemade from a material such as silicone, polyurethane,polytetrafluoroethylene, fluorinated ethylene propylene, polyethylene,expanded polytetrafluoroethylene or other suitable material. FIG. 11,for example, shows an embodiment of the expandable anchor 110 coveredwith a polymer film. The expandable anchor 110 can be made from metal orplastic. The intestinal bypass sleeve 111 can vary in length from 1-2inches in length up to several feet. In some embodiments, the sleevebypasses the length of the duodenum up to the ligament of treitz. Whilevarious embodiments disclosed herein describe the intestinal bypasssleeve as extending into the duodenum, in all such embodiments, it isalso contemplated that the intestinal bypass sleeve has a lengthsufficient to allow it to extend partially or fully into the jejunum.The intestinal bypass sleeve 111 may be made from a thin-walled polymermaterial such as silicone, polyurethane, polytetrafluoroethylene,fluorinated ethylene propylene, polyethylene, expandedpolytetrafluoroethylene (ePTFE) or other suitable material. In exemplaryembodiments, the wall thickness of the intestinal bypass sleeve 111maybe in the range of 0.001 inch to 0.010 inch thick. The intestinalbypass sleeve 111 may be made by extrusion, into a tubular form or a layflat tubing, dip coated from a liquid solution, powder coated from fineparticles of polymer or paste extruded and then stretched as is the casewith ePTFE. As shown in FIG. 5, the intestinal bypass sleeve 111 mayhave optional helical reinforcements 135 made from a polymer or metalapplied to the outer, inner or within the wall thickness of the sleeve.The helical reinforcement can provide for additional kink resistance andprolapse resistance. The wind angle 136 of the helical reinforcement, inexemplary embodiments, has a high pitch angle (for example, 45 degrees)to allow the diameter of the intestinal bypass sleeve to compresseasily. According to various embodiments, the wind angle 136 is in the10 to 85 degrees range. The helical reinforcement may be made integralwith the intestinal bypass sleeve or it may be added in a secondaryprocess by bonding on a monofilament(s) 137 of polymer or wire to thesurface of the sleeve.

FIG. 6 is a drawing of an expandable anchor 110. The expandable anchor110 provides for an anchoring means to hold an intestinal bypass sleeve111 within the small intestine. In exemplary embodiments, the expandableanchor 110 is designed to allow the anchor to be of a self expandingdesign. A self expanding anchor design can be compressed in diameter toallow the device to be compressed in diameter to be loaded onto adelivery catheter. The anchor 110 can then recover elastically to theoriginal starting diameter, with the anchor diameter decreasing only asmall amount due to non elastic recovery. The anchor 110 can also bemade of a plastically deformable design and require a mechanical forceapplied to it in the radial or longitudinal direction to accomplish theexpansion of the anchor. The mechanical force can be accomplished withan inflatable balloon type device, radially expanding the anchor 110, orit may also be accomplished by a longitudinal compression of the anchor110 by a screw type mechanism or cable tensioning means. As shown, theanchor 110 has a proximal portion or proximal disk 144 that is comprisedof 26 spring arms.

As shown, the anchor 110 has a distal portion (e.g., open-endedcylindrical portion) 143 that is comprised of 26 spring arms. Accordingto various embodiments, the anchor 110 could have from 3 to 72 springarms for the proximal disk and the open ended cylinder.

According to exemplary embodiments, the expandable anchor 110 is madefrom a nickel titanium alloys (Nitinol). Other alternative suitablealloys for manufacturing the anchor 110 are stainless steel alloys: 304,316L, BioDur® 108 Alloy, Pyromet Alloy® CTX-909, Pyromet® Alloy CTX-3,Pyromet® Alloy 31, Pyromet® Alloy CTX-1, 21Cr-6Ni-9Mn Stainless,21Cr-6Ni-9Mn stainless, Pyromet Alloy 350, 18Cr-2Ni-12Mn Stainless,Custom 630 (17Cr-4Ni) Stainless, Custom 465® Stainless, Custom 455®Stainless Custom 450® Stainless, Carpenter 13-8 Stainless, Type 440CStainless, cobalt chromium alloys-MP35N, Elgiloy, L605, Biodur®Carpenter CCM alloy, Titanium and titanium alloys, Ti-6Al-4V/ELI andTi-6Al-7Nb, Ti-15Mo, Tantalum, Tungsten and tungsten alloys, pureplatinum, platinum-iridium alloys, platinum-nickel alloys, niobium,iridium, conichrome, gold and gold alloys. The anchor 110 may also becomprised of the following absorbable metals: Pure Iron and magnesiumalloys. The anchor 110 may also be comprised of the following plastics:Polyetheretherketone (PEEK), polycarbonate, polyolefins, polyethylenes,polyether block amides (PEBAX), nylon 6, 6-6, 12, Polypropylene,polyesters, polyurethanes, polytetrafluoroethylene (PTFE) Poly(phenylenesulfide) (PPS), poly(butylene terephthalate) PBT, polysulfone,polyamide, polyimide, poly(p-phenylene oxide) PPO, acrylonitrilebutadiene styrene (ABS), Polystyrene, Poly(methyl methacrylate) (PMMA),Polyoxymethylene (POM), Ethylene vinyl acetate, Styrene acrylonitrileresin, Polybutylene. The anchor 110 may also be comprised of thefollowing absorbable polymeres: Polyglycolic acid (PGA), Polylactide(PLA), Poly(ε-caprolactone), Poly(dioxanone) Poly(lactide-co-glycolide).

The anchor 110, according to exemplary embodiments, is laser cut from around tubing or from a flat sheet of Nitinol and then is rolled into acylindrical shape after laser cutting. The flat representation of theanchor 110 is shown in FIG. 7. The anchor 110, according to exemplaryembodiments, is made from a Nitinol tube of about 9 mm outside diameterby a wall thickness of 0.006 inch thick. Alternatively a starting tubeoutside diameter can range from about 2 mm to 16 mm. An alternativeconstruction method is to laser cut or chemical etch the pattern form aflat sheet of Nitinol with a thickness of 0.002 inch to 0.020 inch.

According to various embodiment, anchor 110 has an inside diameter 139in the range of about 2 mm to 20 mm, Anchor 110 has an expanded open end137 in the range of about 12 mm to 60 mm. Anchor 110 has a disk-shapedfeature 144 that has a diameter 145 in the range of about 12 to 60 mm.Anchor 110 has a central cylinder 138 that has an outside diameter inthe range of 4 to 20 mm. Anchor 110 has a flange 141 adjacent to largediameter open end that has a length of about 8 mm in length. Accordingto various embodiments, this length 141 could range from a length ofabout 1 mm to 30 mm in length. Central cylinder section 138 can have alength 140 of about 1 mm to 30 mm. In various embodiments, the length ofthe cylinder section 138 is about equal to a width of the pylorus 106(e.g., the phyloric sphincter). The proximal disk can have a length of 1mm to 20 mm. The proximal disk 144 can alternatively be formed in theshape of a sphere. The central cylinder 138, in various embodiments, ismade from a material having a stiffness sufficient to resist compressiveforces applied by the pylorus.

FIG. 7 is a drawing of a flat representation of the circumference of theexpandable anchor 110 disclosed in FIG. 6. The anchor 110 can be lasercut from a round tubing or flat sheet of Nitinol. In some embodiments ofthe anchor 110, the edge 146 connects with edge 147 to form a roundtubing.

FIG. 8 is a drawing of a flat representation of the circumference of analternative embodiment of an anchor 148 as disclosed in item 110 of FIG.6. The expandable 148 anchor can be laser cut from round tubing or aflat sheet of Nitinol. The individual spring arm elements of the anchorare cut at a bias angle 149 to the longitudinal axis. The bias angle 149can range from about 1 degree to about 45 degrees. In some embodimentsof the anchor 148, the edge 150 connects with edge 151 to form a tubinghaving a round cross-section.

FIG. 9 is a drawing of heat set mandrels for heat setting (i.e., formthe shape of) the anchor from the laser cut shape of FIG. 7 and FIG. 8to the final shape of the anchor in FIG. 6. Female external mandrel 153is made in two pieces in a clamshell arrangement. Internal mandrel 152is placed within the external mandrel 153 and forms a cavity 154 inbetween the two mandrels and provides a means to shape set the Nitinollaser cut parts as in FIG. 7 and FIG. 8 into formed shape of anchor inFIG. 6. Laser cut part of FIG. 7 or FIG. 8 is placed into mold made ofitems 153 and 152. Mold and anchor is placed in an oven or salt bath ata temperature in the range of 400 to 500 degrees centigrade and held for10 minutes. The mold and anchor is then rapidly cooled by air or a waterbath. An alternative method to heat set the anchor uses a male onlymandrel 155. The laser cut part is longitudinally compressed and clampedon the mandrel 155 to form the shape of the proximal disk.

FIG. 10 is a cross-sectional drawing of a delivery catheter for theinvention herein disclosed. The delivery catheter is composed of thethree coaxial components: distal outer sheath 170, which transitionsdown to a smaller diameter at the proximal outer sheath 182, proximalpusher catheter 171, and sleeve advancement pusher 172. There are threehandles on the catheter: outer sheath handle 173, proximal pusher handle174, and sleeve advancement pusher handle 175. The implant pusher 178serves as a mechanical stop or means to hold stationery or push out theanchor rings 179 or implant from the inside of the distal outer sheath170. The distal tip 176 provides for a flexible tip that will track overa guidewire. The guidewire may be inserted through the central lumen177. The proximal shoulder of the tip 181 is rolled back over the end ofthe intestinal bypass sleeve 180 to constrain the intestinal bypasssleeve 180 to distal tip 176 and the sleeve advancement pusher 172 andto provide a mechanism of advancement of the intestinal bypass sleevethrough the duodenum (and the jejunum as applicable). Expandable anchor179 and the intestinal bypass sleeve 180 are compressed and loaded ontothe delivery catheter.

The distal outer sheath 170 may be made from a plastic polymer such asPebax (polyether block amide), hytrel (polyester elastomer), nylon 12,nylon 11, nylon 6, nylon 6,6, polyethylene, polyurethane or othersuitable polymer. The distal outer sheath 170 may have an inner liningmade from a polymer with a low coefficient of friction such as PTFE. Thedistal outer sheath 170 may also have a metal re-enforcement in the wallthickness to improve the kink resistance or burst properties of theouter sheath. The metal re-enforcement may be comprised of a braidedwire mesh or a coil in the wall thickness. The metal used for the braidmay be stainless steel, Nitinol, MP35N, L605, Elgiloy or other suitablematerial. The distal outer sheath 170 may be from 1-2 inches long up tofull length of the catheter.

The proximal outer sheath 182 may be made from a plastic polymer such asPebax (polyether block amide), Hytrel (polyester elastomer), nylon 12,nylon 11, nylon 6, nylon 6,6, polyethylene, polyurethane or othersuitable polymer. The proximal outer sheath 182 may have an inner liningmade from a polymer with a low coefficient of friction such as PTFE. Theproximal outer sheath 182 may also have a metal re-enforcement in thewall thickness to improve the kink resistance or burst properties of theouter sheath. The metal re-enforcement may be comprised of a braidedwire mesh or a coil in the wall thickness. The metal used for the braidmay be stainless steel, Nitinol, MP35N, L605, Elgiloy or other suitablematerial.

The proximal pusher catheter 171 may be made from a plastic polymer suchas Pebax (polyether block amide), Peek, Hytrel (polyester elastomer),nylon 12, nylon 11, nylon 6, nylon 6,6, polyethylene, polyurethane orother suitable polymer. The proximal pusher catheter 171 may have aninner lining made from a polymer with a low coefficient of friction suchas PTFE. The proximal pusher catheter 171 may also have a metalre-enforcement in the wall thickness to improve the kink resistance orburst properties of the outer sheath. The metal re-enforcement may becomprised of a braided wire mesh or a coil in the wall thickness. Themetal used for the braid may be stainless steel, Nitinol, MP35N, L605,Elgiloy or other suitable material

The sleeve advancement pusher 172 may be made from a plastic polymersuch as Pebax (polyether block amide), Peek, Hytrel (polyesterelastomer), nylon 12, nylon 11, nylon 6, nylon 6,6, polyethylene,polyurethane or other suitable polymer. The sleeve advancement pusher172 may have an inner lining made from a polymer with a low coefficientof friction such as PTFE. The sleeve advancement pusher 172 may alsohave a metal re-enforcement in the wall thickness to improve the kinkresistance or burst properties of the outer sheath. The metalre-enforcement may be comprised of a braided wire mesh or a coil in thewall thickness. The metal used for the braid may be stainless steel,Nitinol, MP35N, L605, Elgiloy or other suitable material. The sleeveadvanced pusher 172 may have a hollow core to allow passage over aguidewire or it may be solid without an opening. The sleeve advancedpusher 172 may also be constructed of a simple tightly wound metal wirecoil construction or it may be wound from multiple wires such as HollowHelical Strand tube made be Fort Wayne Metals. The sleeve advancementpusher handle 175 may also be comprised of a solid tube of Peek, Nitinolor stainless steel. The solid tube may have a series of slots or apatterned on a portion of the tube length to increase the flexibility ofthe component as required.

The distal tip 176 may be molded from Pebax, polyurethane, Hytrel orother suitable elastomer. The distal tip 176 had an outer flange 181that is soft and may rolled back and the intestinal bypass sleeve 180inserted under it to secure the sleeve during transport to the distalduodenum (and the jejunum as applicable).

The delivery catheter handles may be molded or machined from metal orplastic. The outer sheath handle 173 is attached to the proximal outersheath 182. The outer sheath handle 173 is used to hold or retract thedistal outer sheath 170 and the proximal outer sheath 182 during theadvancement of the delivery catheter into the human anatomy, and whiledeploying of the anchoring rings. The proximal pusher handle 174 isattached to the proximal pusher catheter 171. The outer sheath handle173 is used to hold or push forward the proximal pusher catheter 171 andthe implant pusher 178 during the advancement of the delivery catheterinto the human anatomy, and while deploying of the anchoring rings.

An exemplary deployment sequence consists of the following: The deliverycatheter of FIG. 10 is preloaded with the expandable anchor 179 and theintestinal bypass sleeve 180. The delivery catheter is advanced throughthe mouth 100, esophagus 101 and stomach 103 to the pylorus 106. Thesleeve advancement pusher handle 175 is pushed distally while holdingthe rest of the catheter stationary. This pushes the sleeve advancementpusher handle 175, the distal tip 176 and the intestinal bypass sleeve180 into the duodenum (and jejunum as applicable). The pusher handle 175is further advanced until the intestinal bypass sleeve 180 reaches theligament of treiz. At this point all the slack in the sleeve 180 istaken up and the sleeve pulls out from the distal tip 176 and isreleased from the distal tip 176.

FIG. 11 is a sectional view of the invention herein disclosed implantedinto a pylorus 106, duodenal bulb 107 and duodenum 112. The expandableanchor 110 is covered with a membrane 186, 185 on both inside andoutside surfaces of the anchor 110 to close the openings between thespring arm elements 187. An intestinal bypass sleeve 111 is attached tothe expandable anchor 110. The membrane covering the expandable anchormay be made from a thin-walled polymer material such as silicone,polyurethane, polytetrafluoroethylene, fluorinated ethylene propylene,polyethylene, expanded polytetrafluoroethylene (ePTFE) or other suitablematerial. In exemplary embodiments, the wall thickness of the membranecovering the expandable anchor may be in the range of 0.001 inch to0.030 inch thick. The membrane may be made by extrusion, dip coatingfrom a liquid solution, powder coated from fine particles of polymer, orpaste extruded and then stretched (e.g., as is typically done withePTFE). The expandable anchor 110 membrane 185, 186 may also be cut froma flat sheet of material such as ePTFE and then bonded or sewn into adisk shape or spherical shaped structure and then attached theexpandable anchor 110 frame work by sewing or gluing with a polymer suchas FEP. The expandable anchor 110 has a recovery ring 188 attached tothe proximal disk to provide for a location to grab the device forremoval from the human body. Expandable anchor 110 has a central tube194 bonded at location 195, but is free to telescope at location 196 asthe anchor 110 is compressed in diameter and elongated in length toallow loading onto a delivery catheter. The central tube 194 may be madefrom a thin-walled metal material such as stainless steel, titanium orpolymer material such as silicone, polyurethane,polytetrafluoroethylene, fluorinated ethylene propylene, polyethylene,expanded polytetrafluoroethylene (ePTFE) or other suitable material.

FIG. 12 is a sectional view of recovery catheter 197 for removing theexpandable anchor 110 and intestinal bypass sleeve 111 from the humangastrointestinal tract. Recovery catheter has an outer sheath 189, aninner sheath 190, grasper forceps 191, central obturator 192, and aguidewire lumen 193. To remove the expandable anchor 110 and theintestinal bypass sleeve 111, the recovery catheter 197, with aguidewire inserted through the central obturator 192, is advancedthrough the mouth 100, esophagus 101, stomach 103, pyloric antrum 104 upto the pylorus 106. The obturator 192 is inserted into the central lumenof the recovery ring 188. The outer sheath 189 is pulled back to exposeand allow the grasper forceps 191 to open. Grasper forceps 191 is pushedforward over the recovery ring 188 and the outer sheath 189 is theadvanced to collapse grasper forceps 191. The central obturator 192 andgrasper forceps 191 is then pulled into the outer sheath 189 byretraction of the inner sheath 190. The expandable anchor 110 is thenfully collapsed and removed by retraction of the anchor 110 fully intothe outer sheath 189. FIG. 13 is a sectional view of the expandableanchor 110 in the collapsed state within the outer sheath 189 of therecovery catheter covering and constraining the expandable anchor 110.

FIG. 14 is a sectional view of an alternative embodiment of theinvention herein disclosed implanted into a pylorus 106, duodenal bulb107 and duodenum 112. The expandable anchor 110 is covered with amembrane on both the inside 186 and outside 185 surfaces of the anchor110 to close the openings in between the spring arm elements 187. Anintestinal bypass sleeve 111 is attached to the expandable anchor 110.The membrane covering the expandable anchor may be made from athin-walled polymer material such as silicone, polyurethane,polytetrafluoroethylene, fluorinated ethylene propylene, polyethylene,expanded polytetrafluoroethylene (ePTFE) or other suitable material. Insome embodiments, the wall thickness of the membrane covering theexpandable anchor 186 and 185 may be in the range of 0.001 inch to 0.030inch thick. The membrane 186 and 185 may be made by extrusion, dipcoating from a liquid solution. Powder coated from fine particles ofpolymer or paste extruded and then stretched as is the case with ePTFE.The expandable anchor 110 membrane 185, 186 may also be cut from a flatsheet of material such as ePTFE and then bonded or sewn into adisk-shaped or spherical-shaped structure and then attached to theexpandable anchor 110 framework by sewing or gluing with a polymer suchas FEP. The expandable anchor 110 has a recovery ring 188 attached tothe proximal disk to provide for a location to grab the device forremoval from the human body. Expandable anchor 110 has a central tube199, which may be bonded at locations 195 and/or 200. The central tube199 is comprised of an elastomeric material and can elongate in lengthas the anchor 110 is compressed in diameter and elongated in length toallow loading onto a delivery catheter.

The central tube 199 may be made from a thin-walled polymer materialsuch as silicone, polyurethane, polytetrafluoroethylene, fluorinatedethylene propylene, polyethylene, expanded polytetrafluoroethylene(ePTFE) or other suitable material.

FIG. 15 is a sectional view of the invention herein disclosed implantedinto a pylorus 106, duodenal bulb 107 and duodenum 112. The expandableanchor 110 is covered with a membrane on the outside 185 surface of theanchor 110 to close the openings in between the spring arm elements 187.An intestinal bypass sleeve 111 is tapered in diameter and attaches tothe expandable anchor 110 at location 195. Intestinal bypass sleeve 111is sized to fit the duodenum in the duodenal portion and is tapered 201from the larger diameter to the smaller diameter at 196. Intestinalbypass sleeve 111 is not attached to the expandable anchor at 196, butis allowed to slide and telescope within the expandable anchor as it iscompressed in diameter to load the anchor onto a delivery catheter. Themembrane covering the expandable anchor 185 may be made from athin-walled polymer material such as silicone, polyurethane,polytetrafluoroethylene, fluorinated ethylene propylene, polyethylene,expanded polytetrafluoroethylene (ePTFE) or other suitable material. Insome embodiments, the wall thickness of the membrane covering theexpandable anchor 185 may be in the range of 0.001 inch to 0.030 inchthick. The membrane 185 may be made by extrusion, dip coating from aliquid solution, powder coated from fine particles of polymer or pasteextruded and then stretched as is the case with ePTFE. The expandableanchor 110 membrane 185 may also be cut from a flat sheet of materialsuch as ePTFE and then bonded or sewn into a disk shape or sphericalshaped structure and then attached to the expandable anchor 110 framework by sewing or gluing with a polymer such as FEP. The expandableanchor 110 has a recovery ring 188 attached to the proximal disk toprovide for a location to grab the device for removal from the humanbody.

FIG. 16 is a cross-sectional drawing of the invention herein disclosedimplanted into a pylorus 106, duodenal bulb 107 and duodenum 112. Therings are sized large enough in diameter that there is a contact forcebetween the ring diameter and the stomach pyloric antrum 104 and theduodenal bulb 107. The expandable anchor 110 is larger in diameter thanthe maximum opened diameter of the pylorus and therefore provides ananchoring means to hold the intestinal bypass sleeve 111. The intestinalbypass sleeve 111 can vary in length from 1-2 inches in length up toseveral feet. In some embodiments, the sleeve bypasses the length of theduodenum 112 up to the ligament of treitz 109. The intestinal bypasssleeve 111 can also be longer and bypass into the jejunum. The centraltube 194 can be made from a rigid cylinder made from plastic materialsuch as delrin, peek, high density polyethylene, polycarbonate or othersuitable polymer. The central tube 194 may also be made from stainlesssteel, titanium or Nitinol. The fixed diameter of the central tube 194of the device can be sized to provide for a full opening of the pylorusand not allow the pylorus to close normally. In various embodiments, thediameter of the central tube 194 ranges from as small as 3 mm indiameter up to as large as 14 mm in diameter. The central lumen ofdevice has a one-way anti-reflux valve 202. The anti-reflux valve 202allows for unobstructed flow in the direction from the stomach antrum104 to the pylorus 106, but limits flow in the reverse direction. Theanti-reflux valve 202 can be constructed of a duck bill design with twoflexible leaflets 203, or may utilize other designs such as a trileaflet valve 204 or quad leaflet valve 205. The anti-reflux valve maybe constructed of silicone or polyurethane, polyethylene, ePTFE or othersuitable polymer. In various embodiments, the anti-reflux valvefunctions to close an end of the bypass sleeve 111.

The central cylinder 194 may also be constructed to have a flow limiter206. Flow limiter 206 is an orifice that can be added to limit themaximum flow rate of chyme through the central cylinder 202. Inflatableflow limiter 207 may also be added to the central cylinder 194 toprovide for an adjustable means to change the orifice size. Cylindricalhollow balloon 208 on the inside of the central cylinder 194 can beinflated with air 209, saline or a cross-linkable polymer such assilicone to reduce the orifice size. Alternatively the central cylinder194 may also designed to have an optional removable fixed orifice 210.Fixed orifice 210 may be inserted before the device is implanted in ahuman or it can be added or size changed at a later date in the futureif it is so desirable. Fixed orifice 210 can be held into centralcylinder 194 by a magnetic attraction means, snap fit or mechanicalinterlock feature. A mechanical stop 211 can limit how far the fixedorifice 210 inserts into the central cylinder 194. An alternativeembodiment of a flow limiter may also include a compressible mechanicalcage structure 213. The cage structure 213 has a thin tubular membrane214 on the inside. The inside diameter of cage structure 213 can bereduced to 212 by axial compression of the length of the cage structure213, by screwing in collar 215 into inside diameter of central cylinder194. An additional alternative embodiment of a flow limiter can beconfigured to include an obstruction device 216 that is adjustable inposition to change the gap 217 to effectively provide for an adjustableflow limiter. Adjustable flow limiter 216 or 208 may be driven by amotorized method and be adjusted remotely from outside of the patient ata later time by telemetry or magnetic induction.

FIG. 17 is an alternative embodiment of FIG. 16, wherein the anti-refluxvalve is constructed of a ball 218 and cage 219 design. When the ball218 is all the way towards the cage 219 the valve is all the way openand allows flow of chyme from the pyloric antrum 104 to duodenum 112.When the ball 218 is up against the valve seat 220 it is closed and theretrograde flow from the duodenum 112 to the stomach 103 should beminimized. The ball 218 and cage 219 may be constructed of metal orplastics. A bi-leaflet 221 valve may also be suitable for the refluxvalve. The leaflets are in an open position 223 and a closed position222. FIG. 18 is a drawing of an alternative embodiment of an expandableanchor 224. Expandable anchor 224 is comprised of a proximal expandabledisk 225, a distal expandable disk 226, a central cylinder 227 andspring arms 228. The function and materials are similar to the anchordisclosed in FIG. 6. According to various embodiments, the spring armsof the expandable disks extend away from the longitudinal axis at anangle of between about 45 and about 135 degrees.

FIG. 19 is a cross-sectional drawing of expandable anchor disclosed inFIG. 18 and an intestinal bypass sleeve implanted into a pyloric antrum104, pylorus 106 and duodenal bulb 107 and duodenum 112. As shown inFIG. 19, the disks 225 and 226 extend radially outward at an angle ofbetween about 10 and about 30 degrees from perpendicular.

FIG. 20 is a drawing of an alternative embodiment of an expandableanchor 229. Expandable anchor 229 is comprised of a proximal expandablecylinder 230, a distal expandable cylinder 231, a central cylinder 232and spring arms 233. The function and materials are similar to theanchor disclosed in FIG. 6. According to various embodiments, theproximal cylinder 230 further includes a wire, suture, or drawstring283. The drawstring 283 may be used to facilitate collapse and removalof the expandable anchor 229 from the patient. FIG. 21A is a drawing ofa flat representation of the expandable anchor shown in FIG. 20. Cellgeometry is shown in the expanded state 234 and in the compressed state235. FIG. 21B shows embodiments of cylindrical mandrels 236A, 236B forheat setting the expandable anchor to the hour glass shape as in FIG.20.

FIG. 22 is a drawing of an alternative embodiment of an expandableanchor. Expandable anchor is comprised of a proximal disk 237, a distaldisk 238, a central cylinder 239. The central cylinder 239 is laser cutor machined from Nitinol, titanium, stainless steel or other suitablemetal. Alternatively central cylinder is molded from a plastic materialpreviously disclosed in this application. According to variousembodiments, the disks of 237 and 238 are laser cut from a flat sheet ofNitinol in a pattern as in 240 and then heat set into the final shape asin 237 and 238. Formed disk 237 and 238 may be snap fit onto annulargroove 242 of central cylinder 239 by placing hole 241 over annulargroove 242. Expandable anchor may be covered with a polymer covering aspreviously disclosed in this application. According to variousembodiments, the disks 237, 238 extend outwardly substantiallyperpendicular to a longitudinal axis of the anchor.

FIG. 23 is a drawing of an alternative embodiment of an expandableanchor. Expandable anchor is comprised of a proximal disk 243, a distaldisk 244, a central cylinder 245. Central cylinder 245 is machined fromNitinol, titanium, stainless steel or other suitable metal.Alternatively central cylinder is molded from a plastic materialpreviously disclosed in this application. Disk of 243 and 244 may beformed from Nitinol wire in a pattern as in 246. Formed disk 246 may besnap fit onto annular groove 247 of central cylinder 247 by placing hole248 over annular groove 247. Expandable anchor may be covered with apolymer covering as previously disclosed in this application. FIG. 24 isa drawing of expandable anchor of FIG. 23 in a compressed state, with asheath 249 constraining the anchor on the outside diameter.

FIG. 25 is a drawing of an alternative embodiment of an expandableanchor formed from wire. Expandable anchor can be formed from a singleNitinol wire form 250. Central cylinder 251 can be attached to wire form250 by laser welding or adhesive bonding. Wire may be made from Nitinol,stainless steel, Elgiloy, L605, MP35N titanium, niobium or othersuitable metal. The wire can be made of a solid wire, stranded wire orbraided. The outer diameter or inner core of the wire may be clad orplated with gold, tantalum, plantium, iridium or other suitablematerial. The wire may be co-drawn (e.g., drawn filled tube—Fort WayneMetals) and have an outer core of a high strength material such asNitinol, stainless steel, Elgiloy, L605, titanium, niobium and an innercore of a high radio-opacity material such as gold, tantalum, plantium,iridium. Alternatively, the wire is made from plastic monofilament.

FIG. 26 is a drawing of an alternative embodiment of an expandableanchor made from wire. Expandable anchor can be made from a Nitinol wireform as in 253. Wire form 253 is attached to central cylinder 254 byinserting wire ends 256 into a receptacle in central cylinder 254. Wireends of wire form 253, inserted into the central cylinder 254 may beattached to central cylinder by mechanical crimping or adhesive bondingor laser welding. Expandable anchor may be covered with ePTFE aspreviously disclosed to form an hour glass shaped cylinder or selectiveportions 255 can be covered like flower petals. The wire can be made ofa solid wire, stranded wire or braided.

FIG. 27 is a drawing of an alternative embodiment of an expandableanchor formed from wire. Expandable anchor can be formed from Nitinolwire forms 260 and 261. Nitinol wire forms 260 and 261 are disk-shapedand are attached to central cylinder 257, proximal cylinder 258 anddistal cylinder 259 by inserting wire ends into receptacles 262 incylinders 257, 258 and 259. Wire ends of the wire form 260 and 261 areinserted into the central cylinder 257 and may be attached to centralcylinder by mechanical crimping or adhesive bonding or laser welding.The wire can be made of a solid wire, stranded wire or braided.

FIG. 28 is a drawing of an alternative embodiment of an expandableanchor. Expandable anchor is comprised of outer rings 263, 267, innerrings 264, 268 and wires 269. Rings and wire may be made from Nitinol,stainless steel, Elgiloy, L605, MP35N, titanium, niobium or othersuitable material. Alternatively, the rings and wire may be made fromplastics such as Nylon, FEP, PTFE, Delrin, PET, peek, high densitypolyethylene, polycarbonate or other suitable polymer. Outer ring 263and inner ring 264 and wire 269 are bonded together by fusing of thematerials together for example by laser or TIG welding. Entire annularspace 270 between ring 264 and ring 263 can be melted and reflowedtogether to close up the annular space 270 and combine 263, 264 and 269(and also 267, 268 and 269) into one solid mass at the outer ends of thering. Individual wires 269 are not bonded except in the area near theouter ends of the rings. Alternatively, the rings 263, 264, 267, 268 andwires 269 are bonded together by spot welding or adhesive bonding. Thewires may be in the form of round wires 269, flat wires 265, or strandedwires 266. After the rings and wires have been joined together the rings263 and 267 can be compressed towards each other axially to reduce theaxial spacing between the rings and cause the wires 269 to bend andcause the original cylinder shape to transform into a disk-shaped anchor270. Alternatively the anchor can be shaped to form a spherical shape ora barrel shape. The diameter of the rings 263, 264, 267, 268 can rangefrom 3 to 14 mm in diameter and the outer diameter of the disk 270 canrange in the 12 to 50 mm diameter range in the expanded state and in the3 to 14 mm diameter in the unexpanded state. The anchor can be actuatedfrom the collapsed state to the actuated state by mechanical means or bythe elastic properties of the wires 269 which can allow the anchor toself open to the disk-shaped state without mechanical actuation.

FIG. 29 is a drawing of anchor previously disclosed in FIG. 28 in whichthe anchor is formed into alternative shapes. Ring 263 can be rotated inthe opposite direction from ring 267 to form wires 269 to an alternativepattern in which the wires 269 are formed into patterns as in 270 or271. Shape 272 is a disk-shaped anchor with a wire pattern of 270 or271. Shape 274 is a concave shaped disk, wires 269 may be formed intothe pattern of 270, 271 or as in FIG. 28. Shape 273 is a sphericalshaped anchor. Shape 275 is an alternative shape to form the disk.

FIG. 30 is a drawing of an assembly of two of the expandable anchorspreviously disclosed in FIG. 28 and FIG. 29. Anchors 276 and 277 can beany of the alternatives from FIG. 28 and FIG. 29. The anchors areassembled onto a central cylinder 278. The spacing 280 between the twoanchors can be adjusted to accommodate different pylorus widths.Expandable anchors can be covered with a polymer as previously disclosedin this application. FIG. 31 is a cross-sectional view of the pyloricantrum 104, pylorus 106, duodenal bulb 107 and the duodenum 112 in thehuman body. An expandable anchor as disclosed in FIG. 28, FIG. 29 andFIG. 30 and intestinal bypass sleeve 111 is implanted across thepylorus.

FIG. 32 is a drawing of an alternative embodiment of an expandableanchor formed in the shape of a toroidal-shaped coil compression spring282. The toroidal-shaped anchor may be first formed by winding astraight compression spring 281. The compression spring 281 may be madefrom round wire 286, rectangular wire 287, square wire 288 or ellipticalwire 289. The compression spring 281 can be wound to have a round shape290, rectangular shape 291, square shape 292, or an elliptical shape293. The wire may be made from Nitinol, stainless steel, Elgiloy, L605,MP35N titanium, niobium or other suitable metal. The wire is, in variousembodiments, made of a solid wire but can alternatively be made ofstranded or braided wire. The outer diameter or inner core of the wiremay be clad or plated with gold, tantalum, plantium, iridium or othersuitable material. The wire may be co-drawn (e.g., drawn filledtube—Fort Wayne Metals) and have an outer core of a high strengthmaterial such as Nitinol, stainless steel, Elgiloy, L605, MP35N,titanium, niobium and an inner core of a high radio-opacity materialsuch as gold, tantalum, plantium, iridium. Alternatively, the wire ismade from a plastic monofilament such as peek, PET or delrin.Compression spring 281 is formed into a toroidal shape by bending springends towards each other and joining spring ends at connector 295. Aperspective view of the torroidal spring is shown in 294. A drawstring283 is contained within the center of the toroidal spring 282. Thedrawstring 283 is threaded through a hole in the connector 295.Drawstring 283 is terminated at spheres 284 that can be crimped onto theend of the drawstring 283. The spheres may be made of metal or plasticand may be attached to the drawstring 283 by crimping, welding, gluing,insert molding or other suitable means. The drawstring may be comprisedof plastic or metal and may be made of a monofilament or braided cablematerial. When spheres 284 are withdrawn from connector 295, drawstring283 is tensioned and the diameter of the toroidal spring is reduced tothe smaller diameter as in 285.

FIG. 33A is a drawing of an alternative embodiment of an expandableanchor formed in the shape of a toroidal-shaped coil as previouslydisclosed in FIG. 32. The coil may have small tissue penetrating anchors296 on the outer surface of the coil. Tissue penetrating anchor 296 maybe made from, stainless steel, Elgiloy, L605, MP35N, titanium or niobiumand may be crimped onto the wire or welded. Tissue penetrating anchors296 may be an optional feature that can be added if the patient'sanatomy does not have a pyloric ring that is adequate for anchoring.FIG. 33B is a drawing of an alternative embodiment of an expandableanchor formed in the shape of a toroidal-shaped coil as previouslydisclose in FIG. 32. The toroidal-shaped spring is formed of segmentswhere the direction of the winding of the coil is reversed to cancel outthe helical twisting action of the spring. The individual segments 297,298, 299 and 300 can be connector at joiners 301. Alternatively theentire toroidal spring can be laser cut as one unitary piece by lasercutting the wound coil in the unformed shape as in 281 from a piece ofround tubing. FIG. 33C is a drawing of an alternative embodiment of anexpandable anchor formed in the shape of a toroidal-shaped coil aspreviously disclose in FIG. 32. The spring is wound to have doublehelices that are 180 degrees offset from each other.

FIG. 34A is an alternative embodiment of a toroidal spring that is madefrom laser cutting a pattern into a round piece of Nitinol tubing. TheNitinol tubing is laser cut in the straight tubular shape and then thecut tube is then formed into the toroidal shape. Spring elements 301 and302 elastically bend when the diameter of the toroidal spring isreduced. Bending of elements 301 and 302 reduces the included angles 303and 309 and space 304 reduces to allow the diameter of toroidal springto be compressed. FIG. 34B is an alternative embodiment of a toroidalspring that is made from laser cutting a pattern into a round piece ofNitinol tubing. The Nitinol tubing is laser cut in the straight roundtubular shape and then it is formed into the toroidal shape.Alternatively the part may be cut from a flat sheet of Nitinol and thenshape set into the final shape. Spring elements 306 and 305 elasticallybend when the diameter of the toroidal spring is reduced. Bending ofelements 306 and 305 reduces the included angles 307 and angle 308 toallow the diameter of the toroidal spring to be compressed.

FIG. 35 is a drawing of an alternative embodiment of an expandableanchor as disclosed in FIG. 32 and FIG. 33. Toroidal-shaped springs 310,311 and 312 are joined together side-by-side and integrated into ananchor together. In various embodiments, 1 to 3 springs will typicallybe used together, but in some configurations up to 100 springs may bejoined side-by-side at some small spacing. Spring 316, 317 and 318 areassembled in a coaxial arrangement (one spring coaxial within the centerof another) to provide for a combined spring with increased compressionresistance. The direction of the spring winding for the three coaxialsprings may be alternated. Springs 313, 314 and 315 are also coaxialsprings that are wound in an elliptical shape.

FIG. 36 is an assembly drawing of an expandable anchor assembly.Expandable anchor assembly comprises two toroidal springs 327 aspreviously disclosed which are placed into pockets 322 to form disks 319and 320, central cylinder 324 is located in between disks 319 and 320.Pockets 322 are formed from a polymer membrane 321 from materialspreviously disclosed in this application. Polymer membrane 321 isattached to central cylinder at pins 326. Outflow opening 325 providesfor a location to attach the intestinal bypass sleeve 111. Inflowopening 323 is positioned towards the pyloric antrum 104. Drawstring 328can be withdrawn from the toroidal spring assembly to compress andretrieve the device.

FIG. 37 is an assembly drawing of a fixed diameter cylinder for thecentral pyloric portion of the invention herein disclosed. The centralcylinder 324 is ridge and provides a means to attach the polymermembrane to the central cylinder at disks 329 and 330. Securement rings331 and 332 penetrate through holes in the polymer membrane and intoholes in the central cylinder. Securement rings 331 and 332 can befastened to the disks 329 and 330 by diameter interference of the pinswith the holes, by welding, gluing or mechanical fasteners.

FIG. 38 is drawing of a central cylinder pyloric portion for use withany of the anchor embodiments herein disclosed in which the mid-portionallows for normal opening and closing of the pylorus. There is a firstring 333 and a second ring 334 which are fixed rigidly together byconnector links 335, 338 or 337. The connector links cross through thepyloric aperture 105 while not obstructing the pyloric aperture 105 orlimiting opening or closing of the pylorus. In various embodiments, athin polymeric membrane will be used over both rings 333, 334 and willspan the space between the two rings as disclosed in FIG. 39. Thepylorus 106 can close by entering into the space 339 in between rings333 and 334 to open and close. Rigid linking of rings 333 and 334provides for a rigid structure to anchor expandable anchors to and helpsto keep expandable anchor (disks) oriented in the proper orientationwithout canting within the pyloric antrum or duodenal bulb. The rigidlinking also does not allow rotational movement between the two rings333 and 334 and still allows for normal opening and closing of thepylorus, Rotational movement between 333 and 334 may cause the pyloricpolymer membrane 340 portion to close. The expandable anchors in thepyloric antrum and the duodenal bulb are tethered to the first ring 333and second ring 334 by a polymer membrane.

FIG. 39 is a sectional view of the invention herein disclosed implantedinto the pyloric antrum 104, pylorus 106 and duodenal bulb 107 andduodenum 112. The anchoring device is comprised of two disk-shapedexpandable anchors 341 and 342 that are connected to a central cylinderwhich has a thin-walled compliant membrane 340 over the central portionto allow opening and closing of the pyloric aperture. Central cylinderhas rings 333 and 334 which are linked by a connector link 335.Compliant membrane 340 is free to open and close with the movement ofthe pylorus 106. Expandable anchors 341 and 342 are tethered to rings333 and 334 by a polymer membrane 343.

FIG. 40 is a sectional view of the invention herein disclosed implantedinto the pyloric antrum 104, pylorus 106, duodenal bulb 107 and duodenum112. The anchoring device is comprised of two disk-shaped expandableanchors 341, 342 as previously disclosed in this application that areconnected to a rigid central cylinder 344. The lumen of the anchoringdevice has a one way anti-reflux valve 346 and a flow limiter 345.Drawstring 347 can be tensioned to collapse the diameter of theexpandable anchors for removal and for loading the device onto adelivery catheter.

FIG. 41 is a sectional view of the invention herein disclosed implantedinto the pyloric antrum 104, pylorus 106, duodenal bulb 107 and duodenum112. The anchoring device is comprised of two disk-shaped expandableanchors 341, 342 as previously disclosed in this application that areconnected to a central cylinder 350. The tube of central cylinder iselastically compressible in diameter so that the diameter can becompressed from the first state 349 to reduced diameter state 348. Thiswill provide for a smaller profile on the delivery catheter. In someconfigurations, the central cylinder can be soft enough to allow pylorusmovement to compress the central cylinder and close the central cylinderopening when the pylorus closes. Drawstring 347 can be tensioned tocollapse the diameter of the expandable anchors for removal and forloading the device onto a delivery catheter.

FIG. 42 is a sectional view of the invention herein disclosed implantedinto the pyloric antrum 104, pylorus 106, duodenal bulb 107 and duodenum112. The anchoring device is comprised of two disk-shaped expandableanchors 341, 342 as previously disclosed in this application that areconnected to rings 352 and 353. The rings 353, 353 are not rigidlyconnected to each other. Thin-walled central membrane 351 is connectedto the two rings 352 and 353. Central membrane can open and close withthe pylorus. Drawstring 347 can be tensioned to collapse the diameter ofthe expandable anchors for removal and for loading the device onto adelivery catheter.

FIG. 43 is a sectional view of the invention herein disclosed implantedinto the duodenal bulb 107 and duodenum 112. The anchoring device iscomprised of two disk-shaped expandable anchors 341, 342 as previouslydisclosed in this application that are connected to a rigid centralcylinder 344. The lumen of the anchoring device has a one wayanti-reflux valve 346 and a flow limiter 345. Drawstring 347 can betensioned to collapse the diameter of the expandable anchors for removaland for loading the device onto a delivery catheter.

FIG. 44 is a sectional view of the invention herein disclosed implantedinto the pyloric antrum 104, pylorus 106, duodenal bulb 107 and duodenum112. The anchoring device is comprised of two disk-shaped expandableanchors 341, 342 as previously disclosed in this application that areconnected to a rigid central cylinder 344. Drawstring 347 can betensioned to collapse the diameter of the expandable anchors for removaland for loading the device onto a delivery catheter. Intestinal bypasssleeve 111 crosses the pylorus 106 and can be compressed shut at 354 bythe pylorus 106.

FIG. 45A is a sectional view of the invention herein disclosed implantedinto the pyloric antrum 104, pylorus 106, duodenal bulb 107 and duodenum112. The anchoring device is comprised of two disk-shaped expandableanchors 341, 342 as previously disclosed in this application that areconnected to a rigid central cylinder 344. Additional expandable anchors355, 356, 357 and 358 are extended into the pyloric antrum 104.

FIG. 45B is a drawing of a flat braided expandable anchor made fromNitinol wire. A series of dowels pins 504 is press fit into an aluminumplate in a determined pattern. Eight wires 506 are braided into a flatbraid by wrapping the wires around the dowel pins 504 and then braidingone wire over, one wire under. Four wires are braided in each diagonaldirection. Wires are doubled up at end locations 505 and 507. After thebraiding pattern is complete, the wires and the plate are heat set in asalt bath at 500 degrees centigrade for 10 minutes and then waterquenched to room temperature. Heat set wire flat braid 508 is thenremoved from the forming fixture and the wires retain the heat set shapemandrel from the fixture. Flat braid 508 is then wrapped around a roundmandrel to form a cylinder shaped braid 509. The wire ends 505 and 507at the end of the flat braid are joined at 510.

FIG. 46 is a drawing of an alternative embodiment of the inventionherein disclosed. The expandable anchor is comprised of a hollow tubularbraided structure of wire. The tubular braid can be braided in thediameter range from 10 mm in diameter up to about 70 mm in diameter. Thewire diameter can range from 0.001 inch to 0.014 inch. In exemplaryembodiments, the number of wire ends in the braid is 96 ends, but it canrange from as few as 4 ends up to 256 ends. The wire can be made from ametal such as Nitinol, MP35N, L605, Elgiloy, stainless steel or from aplastic such as Pet, Peek or Delrin or other suitable material. Thetubular wire braid is formed into a shape with a disk 360, a centralcylinder portion 363, cylindrical portion 359. Wire ends are gatheredinto bunches 361 and welded together or a sleeve is crimped onto wiresto keep the braided ends from fraying and unraveling. Alternatively, thestructure could be made from a braid using a single wire end. Centralcylinder 363 has a through lumen 362 that allows chyme to flow from thestomach to the duodenum. The central cylinder 363 can be rigid to holdthe pylorus 106 open or it may be compliant to allow the opening andclosure of through lumen 362 with the pylorus.

The length of the device is typically about 50 mm but can range fromabout 10 mm to 100 mm. The diameter of the cylindrical portion 359 istypically about 25 mm in diameter, but can range from 10 mm to 75 mm.The diameter of the central cylinder portion is typically about 10 mm indiameter but can range from 2 mm up to 25 mm in diameter. The length ofthe central cylinder 363 is approximately that of the width of thepylorus, but the central cylinder 363 can be slightly longer to providea gap between central cylinder and pylorus or slightly shorter toprovide for a compressive force to be applied to the pylorus. Theexpandable anchor is compressible in diameter and the diameter can bereduced to about 5 to 10 mm in diameter typically to allow the anchor tobe loaded into a catheter. The expandable anchor can be covered on theoutside and/or inside side with a polymer membrane covering. Themembrane 365 covering the expandable anchor may be made from athin-walled polymer material such as silicone, polyurethane,polytetrafluoroethylene, fluorinated ethylene propylene, polyethylene,expanded poly tetrafluoroethylene (ePTFE) or other suitable material. Insome embodiments, the wall thickness of the membrane covering theexpandable anchor may be in the range of 0.001 inch to 0.030 inch thick.The membrane 365 may be made by extrusion, dip coating from a liquidsolution, powder coated from fine particles of polymer or paste extrudedand then stretched as is the case with ePTFE. The expandable anchormembrane 365 may also be cut from a flat sheet of material such as ePTFEand then bonded or sewn into a disk shape or spherical shaped structureand then attached to the expandable anchor by sewing or gluing with apolymer such as FEP.

FIG. 47 is a sectional view of the invention herein disclosed in FIG. 46implanted into the pyloric antrum 104, pylorus 106, duodenal bulb 107and duodenum 112. An intestinal bypass sleeve 111 is attached to theanchor.

FIG. 48 is a drawing of an alternative embodiment of the inventionherein disclosed in FIG. 46. The expandable anchor is comprised of ahollow tubular braided structure of wire. The wire form has been shapedto conform to the shape of the pylorus and the duodenal bulb. Theexpandable anchor has an annular grove 366 formed in the wall of theduodenal bulb portion of the expandable anchor. The annular groove 366is sized to provide for a modular connection means between an expandableanchor and intestinal bypass sleeve 111. FIG. 49 is a sectional view ofthe invention herein disclosed in FIG. 48 implanted into the pyloricantrum 104, pylorus 106, duodenal bulb 107 and duodenum 112. Anintestinal bypass sleeve 111 is attached to the anchor at annular groove366 and anchored with a second expandable anchor 367.

FIG. 50 is a drawing showing the process steps for the manufacturing ofthe expandable anchor as in FIG. 46, FIG. 47 and FIG. 48. BraidedNitinol wire tube 368 is placed onto mandrel 369, one clamp 370 istightened and then the braid is smoothed and longitudinally tightened onthe mandrel 369. The second clamp 370 is then tightened to secure braid368 onto mandrel. Braid 368, secured on mandrel 369 is then heat set ina salt bath for 5 minutes at a temperature of 500 degrees centigrade.The mandrel and braid is then removed from the salt bath and rapidlycooled by immersing braid and mandrel into a room temperature waterbath. Clamps 370 are then removed from the braid 368 and mandrel 369 andthe braid 368 is removed from the mandrel. One end of heat set braid 368is then inverted through the lumen of 368 to point 371 to form a layerof double braid from the left end to point 371. Braid is then placedonto mandrel 372 and the left end of braid 372 is lined up to point 373.End of overlapped braid is located at 371. Braid is then secured to themandrel 372 at location 374 by a wire clamp and at locations 375 by twoadditional clamps. A secondary heat set is then performed on mandrel 372and braid in a salt bath for 5 minutes at a temperature of 500 degreescentigrade. The mandrel and braid is then removed from the salt bath andrapidly cooled by immersing braid and mandrel into a room temperaturewater bath. Clamps 374, 375 are then removed from the braid and thebraid is removed from the mandrel 372. The braid now has permanentlytaken on the shape of the mandrel 372 and has the narrow centralcylinder 377 shape. The braid length is trimmed at 376. All the ends ofwires in the braid from both layers are at the end of braid at location376. Wire ends are gathered and secured at location 378

FIG. 51 is a drawing of an alternative embodiment of an expandableanchor 379. Expandable anchor 379 is comprised of a proximal expandabledisk 381, a distal expandable disk 380, a central cylinder 382 andspring arms 383. The function and materials are similar to the anchordisclosed in FIG. 18. Spring arms 384 and 385 are formed inwards to formto concave shaped disk surfaces toward the central cylinder 382. Gap 386between disks 380 and 381 can be elastically opened and closed bybending spring arms 384 and 385. FIG. 52A is a drawing of a pyloricantrum 104, pylorus 106, duodenal bulb 107 and duodenum 112 and of theexpandable anchor 379 of FIG. 52. The pylorus width is shown byreference 387. FIG. 52B is a drawing of a pyloric antrum 104, pylorus106, duodenal bulb 107 and duodenum 112 and of the expandable anchor 379of FIG. 52 implanted into it. The pyloric width 387 is greater thananchor width or gap 386. The pyloric width 387 has been reduced to anarrower width 388 due to clamping action of the anchor 379.

FIG. 53 is a drawing of an alternative embodiment of an expandableanchor 389. The function and materials are similar to the anchordisclosed in FIG. 6. Spring arms 392 and 391 are formed inwards to formto concave shaped disk surfaces toward the central cylinder 393. Gap 390between arms 392 and 391 can be elastically opened and closed by bendingspring arms 392 and 391. Expandable anchor 389 can clamp on the pylorusin a similar manner as disclosed in FIG. 52 b.

FIG. 54 is a drawing of an alternative embodiment of a single disk ofexpandable anchor 394 that has optional barbs 395 to provide for anadditional securing means to the pylorus. FIG. 55 is a sectional view ofthe invention herein disclosed implanted into the pyloric antrum 104,pylorus 106, duodenal bulb 107 and duodenum 112. The anchoring device iscomprised of two disk-shaped expandable anchors 394 that are connectedto a central cylinder 396 and 397. The central cylinder of the device396 and 397 in between the two anchor rings 394 can be made from plasticmaterial such as Delrin, peek, high density polyethylene, polycarbonateor other suitable polymer. The central cylinder portion 396, 397 mayalso be made from stainless steel, titanium or Nitinol. The fixeddiameter of the pyloric portion pieces 396 and 397 of the device can besized to provide for a full opening of the pylorus and not allow thepylorus to close normally. The length of the pyloric portion of thedevice 400 can be adjusted by sliding the outer cylinder 396 over innercylinder 397 by sliding on the ratcheting mechanism. This will changethe spacing between the anchor rings 394 and will allow the device to beadjusted for ring spacing in-situ. It may be desirable to change thering spacing to accommodate differences in the pylorus 106 dimensionsfrom patient to patient. It may also be desirable to change the length400 of the central cylinder portion to allow the anchor ring 394 spacingto be adjusted to allow the expandable anchor to put a clamping force onto the pylorus in a longitudinal direction. The mechanism used for 398and 399 could also be a screw thread arrangement such as a male threadon 398 and a female thread on 399. In various embodiments, the insidediameter of the central cylinder 396 and 397 ranges from as small as 2mm in diameter up to as large as 14 mm in diameter. The central lumen ofdevice has a one-way anti-reflux valve 401. The anti-reflux valve 401allows for unobstructed flow in the direction of the stomach antrum 104to the duodenal bulb 107, but limits flow in the reverse direction. Theanti-reflux valve 401 can be constructed of a duck bill design with twoflexible leaflets, or may utilize other designs such as a tri-leafletvalve or quad-leaflet valve. The anti reflux valve may be constructed ofsilicone, polyurethane, polyethylene, ePTFE or other suitable polymer.The diameter of the central cylinder is fixed, but it may also bedesigned to allow it to be reduced in diameter during loading of thedevice onto a catheter.

FIG. 56 is a sectional view of the invention herein disclosed implantedinto the pyloric antrum 104, pylorus 106 and duodenal bulb 107 andduodenum 112. The anchoring device is comprised of two toroidal-shapedexpandable anchors 402 that are connected to a central cylinder 403. Thediameter of the central cylinder 403 is fixed, but it may also beelastic to allow it to be reduced in diameter during loading of thedevice onto a catheter. An optional needle 404, suture, T-bar 405,hollow helical anchor 406 or screw type anchor 407 is inserted intoand/or through the tissue of the pylorus 106, pyloric antrum 104 orduodenum 107 to provide additional anchoring and securement of theintestinal bypass sleeve 111 anchoring device to the pylorus anatomy106. The T-Bar 405 is anchored by a tensioning member 408 and cincher409.

FIG. 57 is a sectional view of the invention herein disclosed implantedinto the pyloric antrum 104, pylorus 106, duodenal bulb 107 and duodenum112. An expandable ring 402 is sized large enough in diameter to engagethe wall of the pyloric antrum 104. The central portion of the device isconstructed of a ridged fixed diameter central cylinder 403, oralternatively a compressible cylinder or a thin-walled sleeve. Anoptional needle 404, suture, T-bar, hollow helical anchor 406 or screwtype anchor 407 is inserted into and or through the tissue of thepylorus 106, pyloric antrum 104 or duodenum 112 to provide additionalanchoring and securement of the intestinal bypass sleeve 111 andanchoring device to pylorus anatomy 106 or other suitable location. TheT-Bar 405 is anchored by a tensioning member 408 and cincher 409.

FIG. 58 is a cross-sectional view of a portion of the digestive tract ina human body. An intestinal bypass sleeve 111 is implanted in theduodenum 112 from the pylorus 106 to the ligament of treitz 109. Thesleeve is held in place at the pylorus 106 by expandable anchors 410that anchor on the pylorus 106 optional secondary expandable anchors 411anchor the intestinal bypass sleeve 111 at additional locations in theduodenum 112 and jejunum 113. An expandable anchor 412 with ananti-reflux valve is implanted at the gastro esophageal (GE) junction102 to help resolve gastroesophageal reflux disease (GERD). Referencenumbers 414, 415, 416, 417, 418 and 419 denote valve designs that havefrom two to seven flaps in the valve and may be used for the anti-refluxdevice 413.

FIG. 59A is a drawing of an alternative embodiment of an expandableanchor. Expandable anchor has a cylindrical portion 420, spring arms421, a central cylinder portion 422, through lumen 423 and an isometricview of the expandable anchor 427. Expandable anchor is laser cut fromNitinol tubing and heat set to final shape on a mandrel with processingsteps as previously disclosed in this application. Large diametercylindrical portion 420 has a diameter in the range from 10 to 70 mm.FIG. 59B is a drawing of an alternative embodiment of an expandableanchor. Expandable anchor has a cylindrical portion 424, spring arms425, through lumen 426 and an isometric view of the expandable anchor428. Expandable anchor is laser cut from Nitinol tubing and heat set tofinal shape on a mandrel with processing steps as previously disclosedin this application. Large diameter cylindrical portion 424, accordingto various embodiments, has a diameter in the range from 10 to 70 mm.FIG. 59C is a drawing of an alternative embodiment of an expandableanchor. Expandable anchor 429 is a double-sided version of anchor as inFIG. 59C. FIG. 60 is a drawing of FIG. 59A and an intestinal bypasssleeve 111 implanted into a pyloric antrum 104, pylorus 106 duodenalbulb 107 and duodenum 112. Alternatively, FIG. 59B and FIG. 59C couldalso be implanted into the pyloric antrum 104, duodenal bulb 107,duodenum 112 or GE junction 102.

FIG. 61A is a drawing of an intestinal bypass sleeve with a diametertransition from a larger diameter to a smaller diameter. Intestinalbypass sleeve is comprised of three sections: a first tube 430, a secondtube 432, and a transitional piece 431. Intestinal bypass sleeve is madefrom a polymer material such as ePTFE, PTFE, FEP, polyurethane,silicone, polyethylene, cross-linked polyethylene, high densitypolyethylene, polypropylene or other suitable material. The intestinalbypass sleeve may be dip coated in one-piece with all three components430, 431, and 432 made into a seamless one-piece unitary structure.Alternatively 430, 431 and 432 can be made as separate components andthey can be joined by adhesive bonding (such as with silicone adhesive)or FEP hot melt adhesive, or they can be sewn together at seams 434,435, 436 using suture such polyester, Nylon, polypropylene, PTFE orePTFE. Intestinal bypass sleeve may range in diameter from 3 to 80 mm.Intestinal bypass sleeve may have a wall thickness in the range of 0.001inch to 0.060 inch thick.

Intestinal bypass sleeve may be made porous or nonporous. Sleeve mayhave surface coatings to close up pores of porous membrane. Such as asurface coating of silicone, polyurethane, FEP applied to poroussubstrate to render it non-permeable. ePTFE is inherently hydrophobicand has some resistance to water penetration, but it may be desirable tohave a higher water entry pressure or make ePTFE impermeable. Intestinalbypass sleeve may have a lubricious (or sticky) hydrophilic coating or ahydrogel added to the inner or outer surface to reduce the friction ofthe surface or to make it easier for food to pass through the liner orto decrease the outer surface coefficient of friction or make the sleevestay in place better in the intestines. Intestinal bypass sleeve orexpandable anchor may be used for drug delivery, delivery of peptides orother therapeutics by incorporating a drug or peptide into the polymerwall thickness of the intestinal bypass sleeve. The drug or peptide maybe added directly to the surface of the intestinal liner without apolymer or covalently bonded to the polymer surface.

The drug or peptide may be eluted from a surface coating on the sleeveor anchor which incorporates the drug into the coating. Polymers thatmay be used as a coating to elute a drug include silicone, polyurethane,Polyvinyl Alcohol, Ethylene vinyl acetate, Styrene acrylonitrile,Styrene-Butadiene, Pebax or other suitable polymer. Absorbable polymersthat may be used for drug delivery include, Polyglycolic acid (PGA),Polylactide (PLA), Poly(ε-caprolactone), Poly(dioxanone)Poly(lactide-co-glycolide) or other suitable polymer. Other suitablecoatings for increased biocompatibility or drug release may includehuman amnion, collagen Type I, II, III, IV, V, VI-Bovine, porcine, orovine. The coating on the intestinal bypass sleeve can also take theform of a liquid that can be used to release the drug or peptideinclude, Vitamin D, A, C, B, E, olive oil, polyethylene glycol,vegetable oils, essential fatty acids, alpha-linolenic acid, lauricacid, linoleic acid, gamma-linolenic acid, palmitoleic acid or othersuitable liquids. The drug may serve to increase satiety, to interruptthe secretion of secondary hormones or digestive enzymes, releaseantibacterial agents to reduce infection, to increase the fibroticreaction of the intestinal tract, to decrease the fibrotic reaction ofthe intestinal tract, to target changes in the cellular composition suchas decreasing the number of receptor cells in the duodenum.

Intestinal bypass sleeve can release cholecystokinin, gastrin, secretin,gastric inhibitory peptide, motilin, glucagon like peptide 1, bile,insulin, pancreatic enzymes, ghrelin, penicillin, amoxicillin,ampicillin, carbenicillin, cloxacillin, dicloxacillin, nafcillin,oxacillin, penicillin g, penicillin V, Piperacillin, TicarcillinAminoglycosides, Amikacin, Gentamicin, Kanamycin, Neomycin, NEO-RX,Netilmicin, Streptomycin, Tobramycin, Carbapenems, Ertapenem, Doripenem,DORIBAX, Emipenem-cilastatin, Meropenem, Cefadroxil, Cefazolin,Cephalexin rapymicin, taxol, vitamin A, vitamin C, vitamin D, vitamin B,vitamin E, fatty acids, oils, vegetable oils, aspirin, somastatin,motilin, trypsinogen, chymotrypsinogen, elastase, carboxypeptidase,pancreatic lipase, amylase, enteroglucagon, gastric inhibitorypolypeptide, Vasoactive intestinal peptide, PYY, Peptide TyrosineTyrosine, Leptin, Pancreatic polypeptide.

FIG. 61B is a drawing of an alternative embodiment of an intestinalbypass sleeve. First tube 437 a V-shaped notch 438 is cut into the topand bottom surfaces of tube. V-shaped notch 438 is closed by sewing oradhesive bonding to reduce the tube diameter 439. Intestinal bypasssleeve is made from ePTFE tubing or other polymers as previouslydisclosed in FIG. 61A.

FIG. 62A is a drawing of an alternative embodiment of an intestinalbypass sleeve. Intestinal bypass sleeve starts out as a round tube 440.Slot 441 is cut into sleeve 440 at the top and bottom surfaces. Slot insleeve 441 is closed by sewing or adhesive bonding at seam 442. Finaltube is an open end tube with a diameter change from the original largerdiameter in 440 to the smaller diameter at 441. FIG. 62B is a drawing ofan alternative embodiment of an intestinal bypass sleeve. Intestinalbypass sleeve starts out as a round tube 443 of ePTFE. Tube diameter isreduced from 444 to 445 by drawing (pulling) the tube 444 through areducing die 446. An optional floating plug 447 can be placed inside oftube during diameter reduction. The final tube is seamless and has alarge diameter section 450, a tapered section 448, and small diametersection 449.

FIG. 63A is a drawing of an alternative embodiment of an intestinalbypass sleeve. Intestinal bypass sleeve starts out as a round tube 451of ePTFE. Tube diameter is increased from 451 to 454 by pulling the tube451 over a mandrel 452. Tube 451 moves in direction 453 while mandrel452 is stationery. The final tube is seamless and has a large diametersection 454, a tapered section 455, and small diameter section 456. Anoptional final tube configuration has a large diameter section 457 and atapered section 458. FIG. 63B is a drawing of an alternative embodimentof an intestinal bypass sleeve. Intestinal bypass sleeve is made byrolling up a thin wall sheet of ePTFE around a mandrel and laminatingthe ePTFE sheet into a tapered tube configuration and sintering orbonding with an adhesive such as FEP. Final tube may have a largediameter section 459 a transition section 460 and a small diametersection 461. Final wall thickness can be formed by 1 to 20 layers 462.

FIG. 64A is drawing of a hemispherical shaped covering for an expandableanchor that is assembled from sheet material into a spherical shape.Figure “8” shape 463 is cut from a sheet of ePTFE sheet. Two shapes of463 are joined together by sewing or adhesive bonding to produce finalspherical shape 465. Spherical shape 465 may have a hole 466 cut throughone or both sides to provide for a through hole to allow attachment toan expandable anchor. FIG. 64B is a drawing of hemispherical shapedcovering for an expandable anchor that is made by radial stretching atube preform into a spherical shape by blow-molding or mechanicalstretching. Starting shape is a tube of ePTFE 467 is tube 467. Tube 467is placed into mold 468 and an internal pressure or force is applied tostretch and radially orient the tube 467 to shape of inside of mold 468.Pressure is released from tube 467 and stretched tube is removed frominside of mold 468. Final shape of tube after removing from mold 468 is469. In FIG. 64C, reference number 511 is a drawing of a multi-lumentubing that can be used for an expandable anchor to hold paralleltoroidal springs as shown in FIG. 35, item 310, 311, 312. Referencenumber 512 is a tubing extrusion with a pre-attached flange to be usedwith an anchor as shown in FIG. 39 and FIG. 65C.

FIG. 65A is drawing of a hemispherical or disk-shaped covering for anexpandable anchor that is assembled from sheet material into a sphericalor disk shape. Shape 466 is cut from a sheet of ePTFE. Multiple sectionsof 466 are joined together into a sphere or disk shape by sewing orjoining the seams by adhesive bonding. An optional throughhole 472 canbe cut through the sphere or disk shape to allow the sphere ordisk-shaped membrane to be attached to the expandable anchor. FIG. 65Bis a drawing of a disk-shaped covering for an expandable anchor that isassembled from sheet material into a disk shape. Shape 473 is cut from asheet of ePTFE. The two items of 473 are placed back-to-back. The outerrims of the two pieces of 473 are joined together by adhesive bondingwith a hot melt of FEP or other suitable adhesive or sewing with suture.The two disks 473 that have been joined together at the outer rim arenow inverted or turned inside out to move the seam to the inside of thedisks 475. FIG. 65C is a drawing of a hemispherical or disk-shapedcovering for an expandable anchor that is assembled from a tube andsheet material into a disk shape. Outer shape toroidal tube 476 is cutfrom a straight piece of ePTFE tube and formed into a toroid by sewingthe tube ends together at 477. In various embodiments, an expandableanchor as in FIG. 32 is inserted inside the tube 476 before the two endsof the tube are joined at 477. Toroidal tube 476 is sewn to flat rounddisk 479 of ePTFE sheet at 478.

FIG. 66 is a drawing of an expandable anchor with toroidal-shapedanchors 480 and 481, expandable anchor has an Archimedes type screw pump484, drive motor 482, battery 485, recharging antennae 486 integratedinto the central cylinder 488 or through a lumen of the device. TheArchimedes screw pump can be used as a means to help treat gastroparesisby actively pumping chyme from the stomach to the small intestine (e.g.,the duodenum). The entire assembly may be placed into the stomach andintestine using an endoscope and delivering the device through thepatient's mouth and stomach to the pylorus. Alternatively some portionsof the device may be surgically placed and may not reside entirelywithin the digestive tract. The pump can also be used in diabeticpatients to more precisely control the flow rate of chyme from thestomach to the small intestine. A more constant and controllable flow ofchyme will allow the diabetic individual to be able to more accuratelycontrol their blood sugar levels. The pump will allow the flow rate ofchyme from the stomach to the small intestine to be varied andcontrolled by the patient.

The Archimedes screw 484 is used to control the flow rate of chymeand/or to pump chyme from the pyloric antrum 104 into the duodenum 112.Battery 485 powers drive motor 482, drive motor 482 turns drive shaft487 and in turn the Archimedes screw 484 is rotated and chyme entersinput side of Archimedes screw 483 and is pumped through to the outputport of pump 489. Output port of pump may incorporate a duck bill typeanti reflex valve to prevent retrograde flow of chyme. The expandableanchor may be used with or without an intestinal bypass sleeve. Thebattery 485 can be remotely charged by inductive charging via theinduction coil or antenna 486. The control of the motor operation, startstop and rotational speed and direction is control by controller 490.Controller 490 can be remotely controlled and programmed by telemetry.Controller can communicate with a controller via telemetry on theoutside of the patients to change the flow rate of chyme. The Archimedesscrew may also be driven magnetically by external magnets (outside thepatient) and internal magnets on Archimedes screw pump.

The flow rate of chyme can be modified depending on the blood glucoselevels of the patient. Blood glucose levels can be continuouslymonitored by a glucose sensor and the insulin infusion rates and chymeflow rates can be controlled by the motor 482 controlling the Archimedesscrew 484 speed. Currently diabetic patients monitor blood glucoselevels and then based on their insulin levels inject themselves withinsulin either with a syringe or with an infusion pump. Gastric emptyingrates vary depending upon the composition of the food eaten. Sugars passquickly from the stomach into the small intestine and protein and fatsmove from the stomach into the small intestine more slowly. Blood sugarcontrol can be difficult to manage if the flow rate of chyme from thestomach to the small intestine is unpredictable and in the case ofpatients with gastroparesis the chyme flow rate can be very slow tozero. The invention herein disclosed will allow for a tighter glucoselevel control by allowing more precise control of the flow rate of chymeinto small intestine and modulating the flow rate of chyme base on bloodglucose levels and insulin infusion rate.

FIG. 67 is a sectional drawing of a part of the gastrointestinalanatomy, a pyloric antrum 104, pylorus 106, duodenal bulb 107 andduodenum 112. The expandable anchor of FIG. 66 is implanted into thepyloric antrum 104, pylorus 106, duodenal bulb 107 and duodenum 112.

FIG. 68 is a cross-sectional drawing of a portion of the digestive tractin a human body. The expandable anchor of FIG. 66 is implanted into thepyloric antrum 104, pylorus 106, duodenal bulb 107 and duodenum 112. Asecondary Archimedes screw type pump 492 is attached to the first pumpby means of a flexible drive shaft 495 and is housed in a hollowflexible cannula 491 that is attached to the expandable anchor. Anoptional intestinal bypass sleeve 111 is attached to the expandableanchor. A blood glucose monitor sensor and an insulin infusion drug pumpcan monitor and adjust the flow rate of chyme from the stomach to thesmall intestine by adjusting the speed of the motor driving theArchimedes screw pump.

FIG. 69A is an alternative embodiment of an expandable anchor.Expandable anchor is comprised of a ring of beads 498 with a throughhole drilled through the bead 500. Beads 498 are threaded onto atensioning cable 499. Tension on tensioning cable 499 is maintained byspring 497. Ring of beads 498 can be deformed into noncircular shape forloading the expandable anchor onto a catheter. The tensioning cableelastically recovers ring shape of beads 498 due to tension exerted byspring on cable. The ring of beads can repeatedly undergo deformation toa non ring shape to a ring shape.

FIG. 69B is an alternative embodiment of an expandable anchor.Expandable anchor is comprised of ring of magnets 502 with a throughhole drilled through the magnets 500. Magnets 498 are threaded onto acable 499. Magnets 502 are loaded onto a tensioning cable 503 with themagnetic poles alternating in polarity. Ring of magnets maintainseparation by magnetic levitation or magnetic repulsion. Magnets 502 canbe deformed into noncircular shape for loading the expandable anchoronto a catheter. The cable and ring of magnets recovers the originalring shape of magnets 502 due to the force exerted by magnets on eachother and the cable. The ring of magnets can repeatedly undergodeformation from a non ring shape to a ring shape.

FIG. 70A is drawing of a piece of ePTFE tubing 504 with a tube 505 ofsilicone or latex inserted through the inside diameter of the ePTFE tube504. The ePTFE tube 504 in the final radially expanded shape can be usedfor covering an expandable anchor used to anchor an intestinal bypasssleeve. The ePTFE covering for the expandable anchor and the intestinalbypass sleeve can be formed into a single unitary tube in someembodiments disclosed. The ePTFE starting tube 504 can be made in auni-axial or a bi-axial orientation. In some embodiments, the finalshape is made by radially expanding the ePTFE tube 504 into the finalshape, alternatively the final shape can also be accomplished bywrapping of thin films of ePTFE sheet into the final shape on a mandreland then laminating them together by sintering the ePTFE layers togetherwith heat or by fusing the ePTFE layers together by using a materialsuch as FEP as a hot melt adhesive. The starting ePTFE tube 504 canrange in size from 3 mm to 12 mm with a wall thickness in the range of0.003 inch to 0.060 inch. The final expanded diameter of the ePTFE tubecan range from the original tube diameter up to 7 times diameterincrease from the original tube diameter. The ePTFE tube is plasticallydeformed during the radial expansion and the diameter largely remains atthe new diameter with some diameter lost, 1 to 20 percent due to recoil.The final diameter of the radially stretched ePTFE tube can range from 3mm to as large as 70 mm. FIG. 70B is a longitudinal cross-sectiondrawing of the ePTFE tube 504 and silicone tube 505 shown in FIG. 70A.FIG. 70C is a drawing of a forming mold 506. The forming mold 506 can bemade from plastic or metal such as aluminum or stainless steel. TheePTFE tube and silicone tube, FIGS. 70A and 70B will be radiallystretched and inflated into the shape of inside of the forming mold 506.The radial expansion of the tube of ePTFE was previously disclosed inFIG. 64B. Two disk-shaped apertures 507 are machined into inside of theforming mold 506.

FIG. 71A is a drawing of two forming molds 506 of FIG. 70C that are usedto provide an enclosed cavity to limit the expansion of the ePTFE tube504 during the blow-molding (radial stretching process). Forming molds506 have disk shape apertures 507 machined into them. The ePTFE tube 504with an inner tube of silicone 505 is place into the forming mold 506.FIG. 71B is a drawing of the forming molds 506 assembled one mold halfon top of the other. The ePTFE tube 504 and silicone tube 505 areinserted through the central bore between the two forming mold halves506. Central lumen of silicone tube 508 is open and provides for apathway to introduce pressurized air or liquid into the lumen ofsilicone tube. Rigid tube 509 surrounds ePTFE tube 504 and silicone tube505. The mold 506, ePTFE tube 504, silicone tube 505 can by heated to anelevated temperature (e.g., a temperature of between about 30-150degrees Celsius) to increase the ultimate elongation of the ePTFE tube504 and the silicone tube 505. The inside of the silicone tube 508 ispressurized with air or liquid to radially expand the ePTFE tube 504into the shape of the central bore and apertures 507. A pressure in therange of 80 psi to 160 psi is typically used to expand the ePTFE tube504 and the silicone tube 505.

FIG. 72A is a drawing of the two forming molds 506 opened after theePTFE tube has been blow molded to the shape of the disk-shapedapertures 507. The ePTFE tube is now permanently formed into the newfinal shape 510. FIG. 72B is a drawing of the formed ePTFE tube 510removed from the mold cavity after the blow-molding/radial stretchingprocess is complete. The ePTFE tube 510 is now permanently formed intothe new final hour glass shape. FIG. 72C is a drawing of thecross-section of the ePTFE tube 504 and silicone tube 505 inflated whilethe two tubes are still in the mold of 71B. After the pressure isreleased the silicone tube 505 elastically returns to its originalstarting diameter and the ePTFE tube 504 partially recoil in diameterbut loses only about 10 to 20 percent of the inflated diameter.

FIG. 73 is a drawing of an alternate embodiment for a shape for theinternal cavity for the forming mold 511 for blow-molding the ePTFEtube. FIG. 74 is a drawing of an alternate embodiment for a shape forthe internal cavity for the forming mold 512 for blow-molding the ePTFEtube. FIG. 75 is a drawing of an alternate embodiment for a shape forthe internal cavity for the forming mold 513 for blow-molding the ePTFEtube. FIG. 76 is a drawing of an alternate embodiment for a shape forthe internal cavity for the forming mold 514 for blow-molding the ePTFEtube.

FIG. 77A is a drawing of the shape of the ePTFE tube formed into adouble disk shape after blow-molding/radial stretching of the originalcylindrical tube of ePTFE. The ends of the radially expanded ePTFE tubeshape may be trimmed in length to accomplish the desired final shape.FIG. 77B is a drawing of the shape of the ePTFE tube formed into adouble disk shape after blow-molding/radial stretching of the originalcylindrical tube of ePTFE. The ends of the radially expanded ePTFE tubeshape may be trimmed in length to accomplish the desired final shape.FIG. 77C is a drawing of the shape of the ePTFE tube formed into adouble cup shape after blow-molding/radial stretching of the originalcylindrical tube of ePTFE. The ends of the radially expanded ePTFE tubeshape may be trimmed in length to accomplish the desired final shape.FIG. 77D is a drawing of the shape of the ePTFE tube formed into a diskand cup shape after blow-molding/radial stretching of the originalcylindrical tube of ePTFE. The ends of the radially expanded ePTFE tubeshape may be trimmed in length to accomplish the desired final shape.FIG. 77E is a drawing of the shape of the ePTFE tube formed into adouble spherical shape after blow-molding/radial stretching of theoriginal cylindrical tube of ePTFE. The ends of the radially expandedePTFE tube shape may be trimmed in length to accomplish the desiredfinal shape.

FIG. 78A is a drawing of the final formed shape of the ePTFE tube afterblow-molding/radial stretching of the original cylindrical tube ofePTFE. The anchor covering portion 515 of the sleeve and the intestinalbypass 516 sleeve are formed integrally into one sleeve. The length 517of the intestinal bypass sleeve 516 may range from a few inches up to 4feet or more. The sleeve may include an optional bulbous shape 518 forthe duodenal bulb. The intestinal bypass sleeve length 517 can rangefrom a few inches to 4 feet or more. FIG. 78B is a drawing of the finalformed shape of the ePTFE tube after blow-molding/radial stretching ofthe original cylindrical tube of ePTFE. The anchor covering portion 515of the sleeve and the intestinal bypass sleeve 516 are formed integrallyinto one sleeve. The small diameter end of the tube 519 is started to beinverted inside to pull it inside to form an interior tube layer for theexpandable anchor. FIG. 78C is a drawing of the final formed shape ofthe ePTFE tube after blow-molding/radial stretching of the originalcylindrical tube of ePTFE. The anchor covering portion of the sleeve 515and the intestinal bypass sleeve 516 are formed integrally into onesleeve. The small diameter end of the tube is fully inverted insideforming an interior layer 521 for the expandable anchor. Two pockets 520are formed with the sleeve, an expandable anchor as previously disclosedin this patent application may be placed within the pockets.

FIG. 79A is a drawing of an alternative embodiment of the final formedshape of the ePTFE tube after blow-molding/radial stretching of theoriginal cylindrical tube of ePTFE. The anchor covering portion of thesleeve 523 and the intestinal bypass sleeve 522 are formed integrallyinto one sleeve. FIG. 79B is a drawing of an alternative embodiment ofthe final formed shape of the ePTFE tube after blow-molding/radialstretching of the original cylindrical tube of ePTFE. The anchorcovering portion of the sleeve 524 and the intestinal bypass sleeve 522are formed integrally into one sleeve. The end of the tube 527 isstarted to be inverted inside to pull it inside to form an interior tubelayer for the expandable anchor. FIG. 79C is a drawing of an alternativeembodiment of the final formed shape of the ePTFE tube afterblow-molding/radial stretching of the original cylindrical tube ofePTFE. The anchor covering portion of the sleeve 528 and the intestinalbypass sleeve 522 are formed integrally into one sleeve. The end of thetube 527 is fully inverted inside forming an interior layer 526 for theexpandable anchor which can be located in pockets 525.

FIG. 80A is a drawing of an alternative embodiment of the final formedshape of the ePTFE tube after blow-molding/radial stretching of theoriginal cylindrical tube of ePTFE. The anchor covering portion of thesleeve 530 and the intestinal bypass sleeve 529 are formed integrallyinto one sleeve. The end of the tube 531 is started to be invertedinside to pull it inside to form an interior tube layer for theexpandable anchor. FIG. 80B is a drawing of an alternative embodiment ofthe final formed shape of the ePTFE tube after blow-molding/radialstretching of the original cylindrical tube of ePTFE. The anchorcovering portion of the sleeve 530 and the intestinal bypass sleeve 529are formed integrally into one sleeve. The small diameter end of thetube is fully inverted inside to pull it inside to form an interior tubelayer 532 for an expandable anchor as previously disclosed.

FIG. 81A is a drawing of an alternative embodiment of the final formedshape of the ePTFE tube after blow-molding/radial stretching of theoriginal cylindrical tube of ePTFE. The anchor covering portion of thesleeve 534 and the intestinal bypass sleeve 533 are formed integrallyinto one sleeve. FIG. 81B is a drawing of an alternative embodiment ofthe final formed shape of the ePTFE tube after blow-molding/radialstretching of the original cylindrical tube of ePTFE. The anchorcovering portion of the sleeve 535 and the intestinal bypass sleeve 533are formed integrally into one sleeve. The end of the tube 537 isstarted to be inverted inside to pull it inside to form an interior tubelayer for the expandable anchor. FIG. 81C is a drawing of an alternativeembodiment of the final formed shape of the ePTFE tube afterblow-molding/radial stretching of the original cylindrical tube ofePTFE. The anchor covering portion of the sleeve 538 and the intestinalbypass sleeve 533 are formed integrally into one sleeve. The end of thetube is fully inverted inside forming an interior layer 536 for theexpandable anchor. The end of the tube is fully inverted inside to pullit inside to form an interior tube layer 532 for an expandable anchor aspreviously disclosed. An expandable anchor may be place in between thelayers at 539.

FIG. 82A is a drawing of an alternative embodiment of the final formedshape of the ePTFE tube after blow-molding/radial stretching of theoriginal cylindrical tube of ePTFE. The anchor covering portion of thesleeve 541 and the intestinal bypass sleeve 540 are formed integrallyinto one sleeve. The small diameter end of the tube is inverted insideto pull it inside to form an interior tube layer for the expandableanchor. The interior tube is formed into the shape of anti-reflux valve542. The anti reflux valve 542 may be formed of two leaflets 545, threeleaflets 546, or four leaflets 547. FIG. 82B is a drawing of analternative embodiment of the final formed shape of the ePTFE tube afterblow-molding/radial stretching of the original cylindrical tube ofePTFE. The anchor covering portion of the sleeve 541 and the intestinalbypass sleeve 540 are formed integrally into one sleeve. The smalldiameter end of the tube is inverted inside to pull it inside to form aninterior tube layer for the expandable anchor. The interior tube isformed into the shape of a restrictive stoma 543. FIG. 82C is a drawingof an alternative embodiment of the final formed shape of the ePTFE tubeafter blow-molding/radial stretching of the original cylindrical tube ofePTFE. The anchor covering portion of the sleeve and the intestinalbypass sleeve are formed integrally into one sleeve. The small diameterend of the tube is inverted inside to pull it inside to form an interiortube layer for the expandable anchor. The interior tube is formed intothe shape of a restrictive stoma and then an anti-reflux valve in series544.

FIG. 83A is a drawing of an alternative embodiment of the final formedshape of the ePTFE tube after blow-molding/radial stretching of theoriginal cylindrical tube of ePTFE. The anchor covering portion of thesleeve 548 and the intestinal bypass sleeve 549 are formed separatelyand bonded together. Intestinal bypass sleeve 549 may be formed from FEPor other suitable polymer. FIG. 83B is a drawing of an alternativeembodiment of the final formed shape of the ePTFE tube afterblow-molding/radial stretching of the original cylindrical tube ofePTFE. The anchor covering portion of the sleeve 550 and the intestinalbypass 551 sleeve are formed integrally into one sleeve. The smalldiameter end of the tube is inverted inside to pull it inside to form aninterior tube layer for the expandable anchor. The intestinal bypasssleeve 551 has annular rings or corrugations formed into it to allow forthe sleeve to bend easier without kinking and to provide for morelongitudinal elasticity.

FIG. 84 is a drawing of an alternative embodiment of the inventionpreviously disclosed in FIG. 46. The expandable anchor is comprised of ahollow tubular braided structure of wire. The wire form has been heatset or shaped to conform to the shape of the pylorus and the duodenalbulb. Optional barbs and/or hooks 552 that have been incorporated intothe anchor to provide for additional tissue penetration and additionalanchoring. FIG. 85 is a drawing of an expandable anchor. The expandableanchor incorporates optional barbs and/or hooks 553 have beenincorporated into the anchor to provide for tissue penetration andadditional anchoring. The barbs are outwardly oriented to engage thetissue of the pyloric antrum, pylorus and/or duodenal bulb. In variousembodiments, the barbs extend outwardly in a direction generallyperpendicular to the longitudinal axis. According to other embodiments,the barbs extend at an angle with respect to the longitudinal axis ofanywhere between about 0 and about 90 degrees. The lengths of the barbsmay range from less than 1 mm up to several mm in length. The barbs maybe constructed from Nitinol, titanium, Elgiloy, MP35N, stainless steel,platinum, platinum iridium, plastics or other suitable materials. Thedesign and construction of the expandable anchor is similar to what waspreviously disclosed in FIG. 6.

FIG. 86 is a drawing of an expandable anchor. The expandable anchorincorporates optional barbs and/or hooks 554 that have been incorporatedinto the anchor to provide for tissue penetration and additionalanchoring. The design and construction of the expandable anchor issimilar to what was previously disclosed in FIG. 6. FIG. 87 is a drawingof an expandable anchor. The expandable anchor incorporates optionalbarbs and/or hooks 555 that have been incorporated into the anchor toprovide for tissue penetration and additional anchoring. The design andconstruction of the expandable anchor is similar to what was previouslydisclosed in FIG. 18. FIG. 88 is a drawing of an expandable anchor. Theexpandable anchor incorporates optional barbs and/or hooks 556 that havebeen incorporated into the anchor to provide for tissue penetration andadditional anchoring. In various embodiments, the barbs extend outwardlyin a direction generally perpendicular to the longitudinal axis.According to other embodiments, the barbs extend at an angle withrespect to the longitudinal axis of anywhere between about 0 and about90 degrees. The design and construction of the expandable anchor issimilar to what was previously disclosed in FIG. 20. FIG. 89 is adrawing of an expandable anchor in which the expandable anchor's antraldisk 557 is larger in diameter than the duodenal bulb disk 558. Thedesign and construction of the expandable anchor is similar to what waspreviously disclosed in FIG. 18.

FIG. 90 is a drawing of an expandable anchor. The expandable anchor hasa central cylinder 559 as previously disclosed in FIG. 38. Theexpandable anchor has an antral disk 560 comprised of Nitinol wire in abraided form and a duodenal disk 561 comprised of Nitinol wire in abraided form. The Nitinol braid can be comprised of a single layer ofbraid or it may be double back on itself and the cut wire ends of thebraid may be attached to the central cylinder at location 589. TheNitinol wire braid may be shape set or formed into the desired shape bythe means previously disclosed in this application.

FIG. 91 is a drawing of an anti-reflux valve for an expandable anchor.The anti-reflux valve 562 can be located within the central cylinder aspreviously disclosed as item 346 in FIG. 40. The anti-reflux valve 562may be made from a thin-walled tube of polymer such as ePTFE, PTFE, FEP,silicone, polyurethane, polyethylene or other suitable polymer. Thepolymer may be designed with the proper thickness and mechanicalproperties to allow the valve to self seal or close when retrograde flowis exerted on the valve. The anti-reflux valve may be bonded to thecentral cylinder 565. Anti-reflux valve is in an open position 566 whenchyme flows from the stomach to the duodenum and in a closed position563 and 564 when chyme flows in a retrograde direction from the duodenumto the stomach. The anti-reflux valve can allow chyme to flow from thestomach to the duodenum without being restricted, but it can also limitor prevent retrograde flow from the duodenum to the antrum. Retrogradeflow from the duodenum to the pylorus can be undesirable and causeeversion of the intestinal bypass sleeve and allow the sleeve to evertthrough the expandable anchor into the stomach. The anti-reflux valve562 can be designed to evert and allow retrograde flows at very highpressures such as during vomiting. The inside diameter of theanti-reflux valve in the open state can range from 4 mm to 18 mm indiameter.

FIG. 92 is a drawing of an anti-reflux valve for an expandable anchor.The anti-reflux valve 568 can be located within the central cylinder aspreviously disclosed as item 346 in FIG. 40. The anti-reflux valve 568may be made from a thin-walled tube of polymer such as ePTFE, PTFE, FEP,silicone, polyurethane, polyethylene or other suitable polymer. Theanti-reflux valve may be bonded to the central cylinder 567. Anti-refluxvalve 568 can have a rigid ring 571 bonded onto the end of the tube toprevent the anti-reflux valve 568 from being everted through the centralcylinder at high pressures. Anti-reflux valve is in an open position 571when chyme flows from the stomach to the duodenum and in a closedposition 569 when chyme flows in a retrograde direction from theduodenum to the stomach. The anti-reflux valve can allow chyme to flowfrom the stomach to the duodenum without being restricted, but it canalso limit or prevent retrograde flow from the duodenum to the antrum.Retrograde flow from the duodenum to the pylorus can be undesirable andcause eversion of the intestinal bypass sleeve and allow the sleeve toevert through the expandable anchor into the stomach.

FIG. 93 is a drawing alternative embodiment of an anti-reflux valve foran expandable anchor. The anti-reflux valve 573 can be located withinthe central cylinder as previously disclosed as item 346 in FIG. 40. Theanti-reflux valve 573 may be made from a thin-walled tube of polymersuch as ePTFE, PTFE, FEP, silicone, polyurethane, polyethylene or othersuitable polymer. The tube can be constructed of one extrusion of tubingor it may be made from three individual sections or leaflets joined toform the circumference of the valve. The anti-reflux valve 573 may bebonded to the central cylinder 572. The polymer tube for the anti-refluxvalve 573 can be attached to the metal flexing post 577. The anti-refluxvalve has three flexing posts 577 at a spacing of about 120 degreesaround the circumference of the valve. The polymer tube can be attachedto the flexing posts by sewing, gluing or other mechanical means. Theflexing posts 577 can be made from metals such as Titanium, Nitinol,stainless steel, elgiloy, MP35N, or plastics such as PEEK or delrin orother suitable material. The flexing posts 577 allows the valve to openat low pressures, but holds the valve leaflets so that they do not evertback into the lumen of the central cylinder 572. Anti-reflux valve is inan open position 574 when chyme flows from the stomach to the duodenumand in a partially closed position 575 and fully closed position 576when chyme flows in a retrograde direction from the duodenum to thestomach. The anti-reflux valve 573 can allow chyme to flow from thestomach to the duodenum without being restricted, but it can also limitor prevent retrograde flow from the duodenum to the antrum. The insidediameter of the anti-reflux valve in the open state can range from 4 mmto 18 mm in diameter.

FIG. 94 is a drawing of an alternative embodiment of an anti-refluxvalve for an expandable anchor. The anti-reflux valve 582 can be locatedwithin the central cylinder as previously disclosed as item 346 in FIG.40. The anti-reflux valve 582 can be made from a thin-walled tube ofpolymer such as ePTFE, PTFE, FEP, silicone, polyurethane, polyethyleneor other suitable polymer. The tube can be constructed of one extrusionof tubing or it may be made from two individual sections or leafletsjoined to form the circumference of the valve. The anti-reflux valve 582may be bonded to the central cylinder 578. The polymer tube for theanti-reflux valve 582 can be attached to the metal flexing posts 579.The anti-reflux valve has two flexing posts 579 at a spacing of about180 degrees around the circumference of the valve. The polymer tube canbe attached to the flexing posts by sewing, gluing or other mechanicalmeans. The flexing posts 579 can be made from metals such as Titanium,Nitinol, stainless steel, elgiloy, MP35N, or plastics such as PEEK ordelrin or other suitable material. The space 583 between the flexingposts can be adjusted to increase the pretension on the leaflets andaffect the opening pressure of the anti-reflux valve. If the postspacing 583 is increased the leaflets will be under greater tension andthe valve opening pressure will be increased. The flexing posts 579 canbe designed to allow the valve to open at low pressures, but the postsstill hold the valve leaflets so that the leaflets do not evert backinto the lumen of the central cylinder 578. Anti-reflux valve is in anopen position 580 when chyme flows from the stomach to the duodenum andin closed position 581 when chyme flows in a retrograde direction fromthe duodenum to the stomach. The opening pressure of the anti-refluxvalve can be designed to be close to zero if little to no flowresistance is desired to the flow of chime from the stomach to theduodenum. To induce additional weight loss in a patient or if a dumpingsyndrome occurs it may be desirable to have the anti-reflux valve thathas a moderate flow resistance in an anti-grade flow direction. The poststiffness or post spacing 583 can be adjusted to customize the desiredflow resistance in the antegrade direction while still maintaining theanti-reflux properties of the valve. Thus the anti-reflux valve 582 canbe designed to accomplish multiple different functions: provide for ananti-reflux function, valve opens at low pressures in an antegrade flowdirection, or valve opens at a higher pressure in the antegrade flowdirection. Previous prior art flow limiters consisted of orifice typevalves. This provides for a flow limiter that can open easily to alarger diameter to allow large food particles to pass through the valvewithout the stretching of a polymer orifice and still provide thedesired flow resistance. Thus this design provides for a flow limiterwithout the inherent risk of having the orifice become obstructed withlarge particles of chyme. The inside diameter of the anti-reflux valvein the open state can range from 4 mm to 18 mm in diameter.

FIG. 95 is a drawing of an alternative embodiment of an anti-refluxvalve frame with flexing posts. The frame is constructed so the flexingposts 585 are integrated into the wall of the central cylinder 584. FIG.96 is a drawing of an alternative embodiment of an anti-reflux valveframe with flexing posts. The flexing posts can be designed to haveholes in the posts 588 or a slot 587 to provide for a means tomechanically attach the leaflets to the flexing posts.

What is claimed is:
 1. A gastrointestinal device for implanting within apylorus, a duodenal bulb, and a duodenum of a patient's gastrointestinaltract, the device having a central axis and configured to have anexpanded configuration and a contracted configuration, the devicecomprising: a proximal expandable structure including an inner proximalportion near the central axis and an outer proximal portion extendingradially outward from the central axis and configured for engaging afirst wall of the pylorus at a first location adjacent the pyloricantrum, the outer proximal portion extending distally such that, uponimplantation, in the expanded configuration, the inner proximal portionis configured to minimize a compressive force exerted to the pylorus; adistal expandable structure including an inner distal portion near thecentral axis and an outer distal portion extending radially outward fromthe central axis and configured for engaging a second wall of thepylorus at a second location adjacent the duodenal bulb, the outerdistal portion extending proximally such that, upon implantation, in theexpanded configuration, the inner distal portion is configured tominimize a compressive force exerted to the pylorus; and a centralcylinder portion coupling the proximal expandable structure and thedistal expandable structure and having a diameter that is equal to orlarger than a maximum diameter of the pylorus such that the centralcylinder portion does not restrict flow through the pylorus; wherein inthe expanded configuration, the proximal expandable structure and distalexpandable structure each have a diameter larger than a maximum openingdiameter of the pylorus.
 2. The gastrointestinal device of claim 1,wherein the proximal expandable structure comprises a compressionspring.
 3. The gastrointestinal device of claim 2, wherein thecompression spring comprises a toroidal-shaped coil.
 4. Thegastrointestinal device of claim 2, wherein the compression springcomprises a shape that consists of a round shape, a rectangular shape, asquare shape or an elliptical shape.
 5. The gastrointestinal device ofclaim 2, wherein the compression spring is configured to have acompressed shape and an expanded shape.
 6. The gastrointestinal deviceof claim 2, wherein the compression spring is formed from a shape memoryalloy.
 7. The gastrointestinal device of claim 1, wherein the centralcylinder portion fits within the pylorus and has a through lumen thatallows chyme to flow from a patient's stomach to the duodenum.
 8. Thegastrointestinal device of claim 1, wherein the central cylinder portionis rigid enough to hold the pylorus open.
 9. The gastrointestinal deviceof claim 1, wherein the central cylinder portion is compliant enough toallow opening and closure of the through lumen within the pylorus.
 10. Agastrointestinal device for implanting within a pylorus, a duodenalbulb, and a duodenum of a patient's gastrointestinal tract andconfigured to have an expanded configuration and a contractedconfiguration, the device comprising: a proximal portion including aproximal facing opening extending radially outward forming a radiallyoutward circumference and a radially inward circumference, the radiallyoutward circumference located distally from the radially inwardcircumference such that the outer radial circumference contacts a wallof a pylorus and wherein upon implantation and in the expandedconfiguration a gap is defined between the inner radial circumferenceand a first wall of the pylorus; a distal portion including a distalfacing opening extending radially outward forming a radially outwardcircumference and a radially inward circumference, the radially outwardcircumference located proximally from the radially inward circumferencesuch that the outer radial circumference contacts a wall of a pylorus;and a central portion having a diameter and a length and located betweenthe proximal portion and the distal portion and connected to theproximal portion inner radial circumference and the distal portion innerradical circumference.
 11. The gastrointestinal device of claim 10,wherein the proximal portion and distal portion are configured to havean expanded configuration and a contracted configuration.
 12. Thegastrointestinal device of claim 10, wherein the distal portioncomprises a compression spring.
 13. The gastrointestinal device of claim12, wherein the compression spring comprises a toroidal-shaped coil. 14.The gastrointestinal device of claim 12, wherein the compression springcomprises a shape that consists of a round shape, a rectangular shape, asquare shape or an elliptical shape.
 15. The gastrointestinal device ofclaim 10, wherein the central portion has a through lumen that allowschyme to flow from a patient's stomach to the duodenum.
 16. Thegastrointestinal device of claim 15, wherein the central portion isrigid enough to hold the pylorus open.
 17. The gastrointestinal deviceof claim 15, wherein the central portion is compliant enough to allowopening and closing of the pylorus.
 18. The gastrointestinal device ofclaim 12, wherein the compression spring is configured to have acontracted configuration and an expanded configuration.
 19. Thegastrointestinal device of claim 12, wherein the compression springcomprises a shape memory alloy.